PARKE-DAVIS TOTAL KNEE PROSTHESIS
FDA 510(k) clearance K800363 · decided 1980-03-10
Clearance details
- K-number
- K800363
- Device name
- PARKE-DAVIS TOTAL KNEE PROSTHESIS
- Applicant
- Warner-Lambert Co.
- Decision
- Substantially Equivalent
- Date received
- 1980-02-20
- Decision date
- 1980-03-10
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- KTZ
- Device class
- 1
- Regulation number
- 888.4150
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, 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 |
|---|---|---|
| NK MEDICAL MICROMETER, MODEL MC001 (K921266) | Nk Biotechnical Engineering Co. | 1992-07-14 |
| SKYNDEX ELECTRONIC BODY FAT CALCULA (K841687) | Caldwell, Justiss & Co., Inc. | 1984-06-28 |
| SCOLIMETER (K831898) | Dr. Micheal A. Sabia | 1983-07-19 |
| A CALIPER (K820659) | Twin City Surgical, Inc. | 1982-03-19 |
| ISOROBIC SKINFOLD CALIPER (K810116) | Fitness Motivation Institute of America | 1981-02-04 |
| TAPE MEASURE (K760521) | Mcgaw Laboratories | 1976-11-12 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AUTOBAC MTS PLUS TEST SYTEM (P810024/S004) | Warner-Lambert Co. | 1988-04-12 |
| AUTOBAC MTS PLUS TEST SYTEM (P810024/S003) | Warner-Lambert Co. | 1986-03-17 |
| AUTOBAC MTS PLUS TEST SYTEM (P810024/S002) | Warner-Lambert Co. | 1986-03-17 |
| AUTOBAC MTS PLUS TEST SYTEM (P810024/S001) | Warner-Lambert Co. | 1983-11-25 |
| AUTOBAC MTS PLUS TEST SYTEM (P810024) | Warner-Lambert Co. | 1982-03-04 |