FASSIER-DUVAL TELSCOPIC IM SYSTEM
FDA 510(k) clearance K041393 · decided 2004-08-17
Clearance details
- K-number
- K041393
- Device name
- FASSIER-DUVAL TELSCOPIC IM SYSTEM
- Applicant
- Pega Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-05-24
- Decision date
- 2004-08-17
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Montreal (Quebec), CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System recall (Z-2941-2024) | ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL | 2024-08-29 |
| Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval recall (Z-1546-2015) | Pega Medical Inc. | 2015-04-29 |
| Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue numbe recall (Z-1472-2014) | Pega Medical Inc. | 2014-04-18 |
| Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part recall (Z-1448-2014) | Pega Medical Inc. | 2014-04-10 |
| Male Driver 4.0mm (catalog # MDr140L) and Male Driver 3.2mm (catalog # MDr132L), an instru recall (Z-1494-2011) | Pega Medical Inc. | 2011-03-02 |