GMK HINGE
FDA 510(k) clearance K130299 · decided 2013-08-15
Clearance details
- K-number
- K130299
- Device name
- GMK HINGE
- Applicant
- Medacta International
- Decision
- Substantially Equivalent
- Date received
- 2013-02-07
- Decision date
- 2013-08-15
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- KRO
- Device class
- 2
- Regulation number
- 888.3510
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Camarillo, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO recall (Z-2661-2017) | Medacta Usa Inc | 2017-06-12 |
| GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery recall (Z-0275-2016) | Medacta Usa | 2015-11-14 |