FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROSTHESIS, PATELLAR ARTICULAR SURFACE
K Number: K760200
·
Decision Jul 20, 1976
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
303
Review Days
12
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PROSTHESIS, PATELLAR ARTICULAR SURFACE
- K Number
- K760200
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Depuy, Inc.
- Date Received
- July 8, 1976
- Decision Date
- July 20, 1976
- Product Code
- JWH
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JWH), ordered by most recent decision date.
NovoKnee (SteriKnee)
FDA 510(k)
FDA Class 2
·Orthopedic
Materialise TKA Guide System
FDA 510(k)
FDA Class 2
·Orthopedic
EMPOWR Knee
FDA 510(k)
FDA Class 2
·Orthopedic
ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom Infinia Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom® Total Knee System Titan PCK Components
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Depuy, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K043058 | PINNACLE CONSTRAINED ACETABULAR LINERS | Mar 14, 2005 | Substantially Equivalent |
| K042664 | LPS UPPER EXTREMITY | Dec 8, 2004 | Substantially Equivalent |
| K041085 | LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY | Jul 22, 2004 | Substantially Equivalent |
| K033959 | LPS | Jul 1, 2004 | Substantially Equivalent |
| K040544 | DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062 | May 28, 2004 | Substantially Equivalent |
| K021478 | DELTA SHOULDER | Nov 18, 2003 | Substantially Equivalent |
| K033329 | DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS | Nov 14, 2003 | Substantially Equivalent |
| K032151 | DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS | Sep 26, 2003 | Substantially Equivalent |
| K020541 | AGILITY ANKLE REVISION PROSTHESIS | May 20, 2002 | Substantially Equivalent |
| K011810 | ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING | Sep 7, 2001 | Substantially Equivalent |