Pega Medical Inc.
FDA Regulatory Profile
Pega Medical Inc. appears in FDA public data with 9 recalls, 12 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2038-2020, Class III) was initiated on April 3, 2020. Its most recent 510(k) clearance was granted on October 24, 2022.
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 12
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2038-2020 | Class III | Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Prod | April 3, 2020 |
| Z-0270-2020 | Class II | SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical ins | October 2, 2019 |
| Z-2278-2019 | Class II | SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System | May 29, 2019 |
| Z-0324-2016 | Class II | SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Scr | October 20, 2015 |
| Z-1848-2015 | Class II | Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogu | June 15, 2015 |
| Z-1546-2015 | Class II | Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telesco | April 10, 2015 |
| Z-1362-2015 | Class II | GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP | February 20, 2015 |
| Z-1472-2014 | Class II | Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040 | March 5, 2014 |
| Z-1448-2014 | Class II | Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M | February 7, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K220190 | The GIRO Growth Modulation System | October 24, 2022 |
| K211292 | Fassier-Duval Telescopic IM System | May 26, 2021 |
| K192710 | The Simple Locking Intramedullary (Slim) System | June 24, 2020 |
| K170704 | The Locking Pediatric Osteotomy Plate (LolliPOP) System | September 8, 2017 |
| K163003 | Y3 Proximal Femoral Plate System | March 16, 2017 |
| K160545 | GAP ENDO-EXO MEDULLARY SYSTEM | November 23, 2016 |
| K143355 | The Simple Locking IntraMedullary (SLIM) System | July 10, 2015 |
| K131591 | FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) | November 27, 2013 |
| K111232 | GAP ENDO-EXO MEDULLARY SYSTEM | January 26, 2012 |
| K090440 | HINGE PEDIATRIC PLATING SYSTEM | May 20, 2009 |
| K041393 | FASSIER-DUVAL TELSCOPIC IM SYSTEM | August 17, 2004 |
| K020885 | FASSIRE-DUVAL TELESCOPIC IM SYSTEM | February 6, 2003 |