VERSAFIT CUP DOUBLE MOBILITY SYSTEM
FDA 510(k) clearance K083116 · decided 2009-04-07
Clearance details
- K-number
- K083116
- Device name
- VERSAFIT CUP DOUBLE MOBILITY SYSTEM
- Applicant
- Medacta International S.A.
- Decision
- Substantially Equivalent
- Date received
- 2008-10-21
- Decision date
- 2009-04-07
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- MEH
- Device class
- 2
- Regulation number
- 888.3353
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26 recall (Z-0878-2013) | Medacta Usa Inc | 2013-02-23 |
| Product Brand Name: Versafitcup Double Mobility Liner Inserter Product Generic Name: Versa recall (Z-2709-2011) | Medacta Usa Inc | 2011-06-30 |