FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRK CONDYLAR RESURFACING TOTAL KNEE
K Number: K915584
·
Decision Feb 12, 1993
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
9
Review Days
427
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Basic Information
- Device Name
- CRK CONDYLAR RESURFACING TOTAL KNEE
- K Number
- K915584
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Implantology Corp.
- Date Received
- December 13, 1991
- Decision Date
- February 12, 1993
- 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 |
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Other Clearances by Implantology Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K934729 | UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED | Jul 22, 1994 | Substantially Equivalent for Some Indications |
| K915529 | FPC/SFPC/RFPC ACETABULAR COMPONENT | Jul 13, 1993 | Substantially Equivalent |
| K915528 | BHR BIPOLAR FEMORAL HEAD COMPONENT | Jun 29, 1993 | Substantially Equivalent |
| K915527 | CPS ACETABULAR COMPONENT | Jun 24, 1993 | Substantially Equivalent |
| K915385 | PPC HIP STEM COMPONENT | May 17, 1993 | Substantially Equivalent for Some Indications |
| K924099 | UFC HIP STEM COMPONENT | Apr 30, 1993 | Substantially Equivalent |
| K915391 | FPC HIP STEM COMPONENT | Apr 30, 1993 | Substantially Equivalent |
| K915798 | PSK POSTERIOR STABILIZED TOATAL KNEE | Mar 4, 1993 | Substantially Equivalent |