FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
P.M. HIP-FEMORAL PROSTHESIS
K Number: K853916
·
Decision Dec 27, 1985
Classifications
1
FEI Numbers
227
Registration Numbers
227
Same Product Code
562
Applicant Total
22
Review Days
95
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Basic Information
- Device Name
- P.M. HIP-FEMORAL PROSTHESIS
- K Number
- K853916
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Advanced Biosearch Assn.
- Date Received
- September 23, 1985
- Decision Date
- December 27, 1985
- Product Code
- JDI
- 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | FDA class 2 | Orthopedic |
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Other Clearances by Advanced Biosearch Assn.
| K Number | Device Name | ||
|---|---|---|---|
| K905514 | AUTOGENESIS(TM) AUTOMATOR | Apr 2, 1991 | Substantially Equivalent |
| K883888 | CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. | Dec 12, 1988 | Substantially Equivalent |
| K854770 | MARTIN LAMINAR OSTEOSYNTHESIS SYSTEM | Feb 11, 1986 | Substantially Equivalent |
| K855030 | CHAMPY BONE PLATES & BONE SCREWS | Jan 30, 1986 | Substantially Equivalent |
| K855031 | MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P | Jan 21, 1986 | Substantially Equivalent |
| K852839 | FREEMAN HIP | Oct 29, 1985 | Substantially Equivalent |
| K853418 | SAFTI-BRACELET | Sep 20, 1985 | Substantially Equivalent |
| K852517 | CLS HIP PROSTHESIS | Sep 18, 1985 | Substantially Equivalent |
| K852699 | FREEMAN ACETABULAR CUP | Sep 5, 1985 | Substantially Equivalent |
| K850773 | PM CEMENTLESS SCREW-IN ACETABULAR CUP | May 2, 1985 | Substantially Equivalent |