Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Johnson & Johnson. FDA records under 4 spellings of its name, each linked to the record. See the Johnson & Johnson group view.
As of Nov 15, 2026, FDA's public records list DePuy Spine with 75 510(k) clearances and 36 device recalls. The most recent is a 510(k) clearance dated Oct 15, 2022: CONDUIT Cages; FIBERGRAFT BG Putty.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 15, 2022 | CONDUIT Cages; FIBERGRAFT BG PuttyK222276 · ODP | 510(k) clearances |
| May 20, 2022 | EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion inClass II · Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labe | Device recalls |
| May 20, 2022 | EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion inClass II · Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labe | Device recalls |
| Aug 31, 2020 | CONFIDENCE Spinal Cement SystemK201831 · NDN | 510(k) clearances |
| Apr 8, 2019 | Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (19Class II · A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants. | Device recalls |
| Apr 8, 2019 | Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27Class II · A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants. | Device recalls |
| Dec 15, 2017 | Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) ThClass II · Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or i | Device recalls |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm Item Code: 186852026 The SKYLINE¿ Anterior CeClass II · SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Device recalls |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm Item Code: 186862018 The SKYLINE¿ Anterior Class II · SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Device recalls |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm Item Code: 186852020 The SKYLINE¿ Anterior CerClass II · SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Device recalls |
| Nov 19, 2014 | EXPEDIUM VERSE SPINE SYSTEMK142185 · NKB | 510(k) clearances |
| Sep 12, 2013 | EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEMK131802 · OSH | 510(k) clearances |
| Jun 14, 2012 | EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEMK111136 · NKB | 510(k) clearances |
| May 3, 2012 | VIPER SYSTEMK121020 · NKB | 510(k) clearances |
| Apr 7, 2011 | MOUNTAINEER OCT SPINAL SYSTEMK110353 · KWP | 510(k) clearances |
| Apr 1, 2011 | EXPEDIUM SYSTEM, VIPER SYSTEMK110216 · NKB | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
