FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP
FDA 510(k) clearance K853730 · decided 1986-02-18
Clearance details
- K-number
- K853730
- Device name
- FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP
- Applicant
- Protek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-09-06
- Decision date
- 1986-02-18
- Days to decision
- 165 days
- Clearance type
- Traditional
- Product code
- MBV
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Indianapolis, IN, 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.
| Record | Firm | Date |
|---|---|---|
| OFFSET TIBIAL TRAY (K010212) | Biomet, Inc. | 2001-02-14 |
| TRICON-M TOTAL KNEE SYSTEM (K884824) | Richards Medical Co., Inc. | 1989-11-21 |
| FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE (K873429) | Protek, Inc. | 1987-10-28 |
| TRICON M TOTAL KNEE SYSTEM (K833200) | Richards Medical Co., Inc. | 1983-11-29 |
| POROCOAT FREEMAN/SAMUELSON TOTAL KNEE (K831441) | Depuy, Inc. | 1983-09-01 |
| MARK I TOTAL KNEE SYS. ARTHROPLASTY (K832302) | Advanced Biosearch Assn. | 1983-08-16 |
| MARK I & II TOTAL KNEE REPLACE. SYS (K830726) | Advanced Biosearch Assn. | 1983-06-22 |
| RMC TOTAL KNEE SYSTEM (K823837) | Richard'S Medical Equip., Inc. | 1983-03-29 |
| FREEMAN/SAMUELSON TOTAL KNEE (K830408) | Depuy, Inc. | 1983-02-24 |
| TOTAL KNEE SYSTEM (K822583) | Richard'S Medical Equip., Inc. | 1982-10-04 |
| ICLH TIBIAL PLATEAU (K802921) | Depuy, Inc. | 1981-01-08 |
| KNEE, TOTAL, FEMORAL & TIBIAL (K780904) | Depuy, Inc. | 1978-06-22 |
Recalls involving this device
No recalls on record reference this clearance.