Company ยท CA
Pega Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2022. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
8recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 24, 2022 | K220190 | The GIRO Growth Modulation System Pega Medical, Inc., CA | OBT |
| May 26, 2021 | K211292 | Fassier-Duval Telescopic IM System Pega Medical, Inc., CA | HSB |
| Jun 24, 2020 | K192710 | The Simple Locking Intramedullary (Slim) System Pega Medical, Inc., CA | HSB |
| Sep 8, 2017 | K170704 | The Locking Pediatric Osteotomy Plate (LolliPOP) System Pega Medical, Inc., CA | KTT |
| Mar 16, 2017 | K163003 | Y3 Proximal Femoral Plate System Pega Medical, Inc., CA | HRS |
| Nov 23, 2016 | K160545 | GAP ENDO-EXO MEDULLARY SYSTEM Pega Medical, Inc., CA | HSB |
| Jul 10, 2015 | K143355 | The Simple Locking IntraMedullary (SLIM) System Pega Medical, Inc., CA | HSB |
| Nov 27, 2013 | K131591 | FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) Pega Medical, Inc., CA | HWC |
| Jan 26, 2012 | K111232 | GAP ENDO-EXO MEDULLARY SYSTEM Pega Medical, Inc., CA | HSB |
| May 20, 2009 | K090440 | HINGE PEDIATRIC PLATING SYSTEM Pega Medical, Inc., CA | HRS |
| Aug 17, 2004 | K041393 | FASSIER-DUVAL TELSCOPIC IM SYSTEM Pega Medical, Inc., CA | HSB |
| Feb 6, 2003 | K020885 | FASSIRE-DUVAL TELESCOPIC IM SYSTEM Pega Medical, Inc., CA | HSB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2020 | Pega Medical Inc. Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures. Terminated |
LXH | None listed |
| Oct 2, 2019 | Pega Medical Inc. SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery Terminated |
LXH | None listed |
| May 29, 2019 | Pega Medical Inc. SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System Terminated |
HSB | K143355 |
| Nov 20, 2015 | Pega Medical Inc. SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System.
This instrument is included in the Free Gliding SCFE Screw System instrument tray. This Terminated |
HWC | K131591 |
| Jun 26, 2015 | Pega Medical Inc. Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273. Terminated |
HWC | K131591 |
| Apr 29, 2015 | Pega Medical Inc. Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures.
This instrument is included in the Fassier-Duval IM Teles Terminated |
HSB | K020885 K041393 |
| Apr 2, 2015 | Pega Medical Inc. 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.
Product Usage:
The GAP Endo-Exo Medullary System is used for the t Terminated |
HSB | K111232 |
| Apr 18, 2014 | Pega Medical Inc. Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS.
-Duval IM Telescopic System. Terminated |
HSB | K020885 K041393 |
| Apr 10, 2014 | Pega Medical Inc. Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod. Terminated |
HSB | K020885 K041393 |
| Mar 2, 2011 | Pega Medical Inc. Male Driver 4.0mm (catalog # MDr140L) and Male Driver 3.2mm (catalog # MDr132L), an instrument used for the insertion of the Fassier-Duval Telescopic IM System intramedullary nail, for bone fixation. Terminated |
HSB | K020885 K041393 |