BIO-MODULAR REVERSE SHOLDER
FDA 510(k) clearance K093803 · decided 2010-10-19
Clearance details
- K-number
- K093803
- Device name
- BIO-MODULAR REVERSE SHOLDER
- Applicant
- Biomet Manufacturing Corp
- Decision
- Substantially Equivalent
- Date received
- 2009-12-11
- Decision date
- 2010-10-19
- Days to decision
- 312 days
- Clearance type
- Traditional
- Product code
- PHX
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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|---|---|---|
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| Oxford® Partial Knee System (P010014/S106) | Biomet Manufacturing Corp | 2024-08-19 |
| Oxford Partial Knee (P010014/S104) | Biomet Manufacturing Corp | 2023-04-06 |