Pega Medical, Inc.
Pega Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 2003, most recent 2022, with 9 FDA device recalls on record.
Top product codes for Pega Medical, Inc.
FDA recalls by Pega Medical, Inc.
- Z-2038-2020 — 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.
- Z-0270-2020 — SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
- Z-2278-2019 — SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System
- Z-0324-2016 — 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 instrument is marked with the catalogue number and lot number. The Free-Gliding SCFE Screw System is a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in pediatric patients. Orthopedic.
- Z-1848-2015 — Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
- Z-1546-2015 — 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 Telescopic System instrument tray. This instrument is marked with the catalogue number and lot number.
- Z-1362-2015 — 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. Product Usage: The GAP Endo-Exo Medullary System is used for the treatment of fractures or correction of deformities in the femur, tibia and humerus of pediatric patients, who have reached skeletal maturity. The GAP Nail is an intramedullary nail. It is the main component of the GAP Endo-Exo Medullary System. The rest of the components of the system are screws, plates and caps that are assembled to the nail during the surgical procedure. The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of: long bones that have been surgically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP System is used for pediatric patients (child and adolescent) ages 2 to 21. It can be used to correct the following conditions: -Diaphyseal fracture of the femur, tibia and humerus -Fractures of the femoral neck -Subtrochanteric, intertrochanteric and combination fractures -Correction of deformities (OI, Coxa vara, Coxa valga) -Nonunions and malunions
- Z-1472-2014 — Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.
- Z-1448-2014 — 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Pega Medical, Inc.
- K220190 — The GIRO Growth Modulation System
- K211292 — Fassier-Duval Telescopic IM System
- K192710 — The Simple Locking Intramedullary (Slim) System
- K170704 — The Locking Pediatric Osteotomy Plate (LolliPOP) System
- K163003 — Y3 Proximal Femoral Plate System
- K160545 — GAP ENDO-EXO MEDULLARY SYSTEM
- K143355 — The Simple Locking IntraMedullary (SLIM) System
- K131591 — FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)
- K111232 — GAP ENDO-EXO MEDULLARY SYSTEM
- K090440 — HINGE PEDIATRIC PLATING SYSTEM
- K041393 — FASSIER-DUVAL TELSCOPIC IM SYSTEM
- K020885 — FASSIRE-DUVAL TELESCOPIC IM SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.