S-ROM/NOILES MARK 3
FDA 510(k) clearance K896048 · decided 1990-03-14
Clearance details
- K-number
- K896048
- Device name
- S-ROM/NOILES MARK 3
- Applicant
- Joint Medical Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-10-18
- Decision date
- 1990-03-14
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- KRO
- Device class
- 2
- Regulation number
- 888.3510
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Stamford, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left recall (Z-1203-2014) | DePuy Orthopaedics, Inc. | 2014-03-13 |
| REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Rig recall (Z-1204-2014) | DePuy Orthopaedics, Inc. | 2014-03-13 |
| REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Lef recall (Z-1205-2014) | DePuy Orthopaedics, Inc. | 2014-03-13 |
| REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Righ recall (Z-1206-2014) | DePuy Orthopaedics, Inc. | 2014-03-13 |
| REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left recall (Z-1207-2014) | DePuy Orthopaedics, Inc. | 2014-03-13 |
| REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right recall (Z-1208-2014) | DePuy Orthopaedics, Inc. | 2014-03-13 |