REVERSE SHOULDER PROSTHESIS
FDA 510(k) clearance K092873 · decided 2009-10-27
Clearance details
- K-number
- K092873
- Device name
- REVERSE SHOULDER PROSTHESIS
- Applicant
- Djo Surgical
- Decision
- Substantially Equivalent
- Date received
- 2009-09-18
- Decision date
- 2009-10-27
- Days to decision
- 39 days
- Clearance type
- Special
- Product code
- PHX
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM (N980003/S007) | Djo Surgical | 2009-02-13 |
| KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM (N980003) | Djo Surgical | 2003-11-26 |