Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in CanadaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Pega Medical Inc. with 12 510(k) clearances and 9 device recalls. The most recent is a 510(k) clearance dated Oct 24, 2022: The GIRO Growth Modulation System.
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 24, 2022 | The GIRO Growth Modulation SystemK220190 · OBT | 510(k) clearances |
| May 26, 2021 | Fassier-Duval Telescopic IM SystemK211292 · HSB | 510(k) clearances |
| Jun 24, 2020 | The Simple Locking Intramedullary (Slim) SystemK192710 · HSB | 510(k) clearances |
| Apr 3, 2020 | Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip fClass III · The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label. | Device recalls |
| Oct 2, 2019 | SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgeryClass II · There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may c | Device recalls |
| May 29, 2019 | SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) SystemClass II · Handle could jam with the Driver due to the detachment of an internal Connector Ring. | Device recalls |
| Sep 8, 2017 | The Locking Pediatric Osteotomy Plate (LolliPOP) SystemK170704 · KTT | 510(k) clearances |
| Mar 16, 2017 | Y3 Proximal Femoral Plate SystemK163003 · HRS | 510(k) clearances |
| Nov 23, 2016 | GAP ENDO-EXO MEDULLARY SYSTEMK160545 · HSB | 510(k) clearances |
| Oct 20, 2015 | SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is includClass II · SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw. | Device recalls |
| Jul 10, 2015 | The Simple Locking IntraMedullary (SLIM) SystemK143355 · HSB | 510(k) clearances |
| Jun 15, 2015 | Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.Class II · SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instruments may detach from th | Device recalls |
| Apr 10, 2015 | Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. Class II · The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0.06 mm under the specif | Device recalls |
| Feb 20, 2015 | GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28. ProdClass II · Failures of the 4.8mm of the GAP Endo-Exo Medullary System have been identified at the level of the distal cortical scre | Device recalls |
| Mar 5, 2014 | Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. Class II · The outer package label contained the incorrect length of the device. There is a label on the outer package and an addit | Device recalls |
| Nov 27, 2013 | FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)K131591 · HWC | 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
