PROFIX CONFORMING PLUS TIBIAL INSERT
FDA 510(k) clearance K946236 · decided 1995-07-06
Clearance details
- K-number
- K946236
- Device name
- PROFIX CONFORMING PLUS TIBIAL INSERT
- Applicant
- Smith & Nephew Richards, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-12-22
- Decision date
- 1995-07-06
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- KWH
- Device class
- 2
- Regulation number
- 888.3720
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OSTEOPAL (P810020/S005) | Smith & Nephew Richards, Inc. | 1998-10-15 |
| PALACOS E-FLOW (OSTEOPAL) BONE CEMENT (P810020/S004) | Smith & Nephew Richards, Inc. | 1998-07-30 |
| PALACOS R BONE CEMENT (P810020/S003) | Smith & Nephew Richards, Inc. | 1992-02-14 |
| PALACOS R BONE CEMENT (P810020/S002) | Smith & Nephew Richards, Inc. | 1989-01-30 |
| PALACOS R BONE CEMENT (P810020/S001) | Smith & Nephew Richards, Inc. | 1984-08-14 |
| PALACOS R BONE CEMENT (P810020) | Smith & Nephew Richards, Inc. | 1984-02-02 |