Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
FDA establishment 3004491689, Greenwood Village, Colorado, United States. Part of ConMed's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 7
Official action indicated: 1
Last inspection ended: Apr 6, 2026
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 830.310(b). GUDID Information required for unique device identification. The correct unique device identifier (UDI) information regarding device identifier portion of the UDI assigned to the version or model was not provided to the FDA via the Global Unique Device Identification Database (GUDID).
21 CFR 806.10(a)(2). Report of violation of the Act (see 803.52(e)(9)) A violation of the FD&C Act involving a device which might present a risk to health was not reported to FDA.
ISO 13485:2016 Clause 7.3.1. Design and development procedures not documented Design and development procedures were not adequately documented.
ISO 13485:2016 Clause 8.5.2. Corrective action procedures not documented Corrective action procedures defining the requirements for determining the causes of nonconformities and planning and documenting action needed and implementing such action have not been adequately documented.
ISO 13485:2016 Clause 8.2.2. Complaint handling procedures lack required elements Procedures for timely complaint handling do not adequately include requirements and responsibilities for receiving and recording information, investigating complaints and handling of complaint-related product.
ISO 13485:2016 Clause 7.3.9. Procedures to control design and development changes not documented Procedures to control design and development changes were not adequately documented.
Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices; Devices · Radiation Control and Health Safety Act
12 cited references
21 CFR 820.30(g). Design Validation - Risk analysis not performed/inadequate Risk analysis is incomplete.
21 CFR 820.72(a). Equipment suitability & capability Certain inspection and measuring equipment is not suitable for its intended purposes and capable of producing valid results.
21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures have not been adequately established to control product that does not conform to specified requirements.
21 CFR 820.90(a). Nonconforming product control Products that do not conform to specifications are not adequately controlled.
21 CFR 820.80(e). Documentation Acceptance activities were not documented and maintained as part of the device history record.
21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change have not been adequately established.
21 CFR 820.75(a). Lack of or inadequate process validation A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
21 CFR 820.184. Lack of or inadequate DHR procedures Procedures for device history records have not been established.
21 CFR 1002.12. Not submitted prior to introduction You did not submit an abbreviated report, required by 21 CFR 1002.1, prior to introduction of the product.
21 CFR 820.70(c). Environmental control Lack of or inadequate procedures Procedures to control environmental conditions have not been established.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.75(a). Lack of or inadequate process validation A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
21 CFR 820.90(a). Nonconforming product control Products that do not conform to specifications are not adequately controlled.
21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been established.
21 CFR 820.30(a). Design control - no procedures Procedures for design control have not been established.
21 CFR 820.25(b). Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been adequately established.
21 CFR 820.80(a). Lack of or inadequate procedures - Acceptance activities Procedures for acceptance activities have not been established.
21 CFR 820.30(g). Design validation - software validation not performed Validation of device software is incomplete.
21 CFR 820.30(h). Design transfer - Lack of or inadequate procedures Procedures for design transfer have not been adequately established.
21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change have not been adequately established.
21 CFR 820.30(f). Design verification - output does not meet input requirement Design verification does not confirm that design output meets design input requirements.
21 CFR 820.90(b)(2). Product rework documentation, DHR {see also 820.184} Rework and reevaluation activities have not been documented in the device history record.
21 CFR 820.30(g). Design Validation - Risk analysis not performed/inadequate Risk analysis is incomplete.
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard and warning letters
Greenwood Village, Colorado, United States. Part of