FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESUBMITTED CLW ACETABULAR CUP W/SULMESH
K Number: K883794
·
Decision May 26, 1989
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
80
Applicant Total
25
Review Days
261
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Basic Information
- Device Name
- RESUBMITTED CLW ACETABULAR CUP W/SULMESH
- K Number
- K883794
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Protek, Inc.
- Date Received
- September 7, 1988
- Decision Date
- May 26, 1989
- Product Code
- LWJ
- 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 |
|---|---|---|---|
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | FDA class 2 | Orthopedic |
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Other Clearances by Protek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K893785 | ARC-2F ACETABULAR CUP | Aug 9, 1989 | Substantially Equivalent for Some Indications |
| K893959 | P.S.A. FEMORAL HIP PROSTHESIS | Jul 25, 1989 | Substantially Equivalent |
| K892059 | FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR | Jul 19, 1989 | Substantially Equivalent |
| K884952 | VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC | May 10, 1989 | Substantially Equivalent |
| K884889 | MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP. | Feb 27, 1989 | Substantially Equivalent |
| K884789 | NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI | Feb 8, 1989 | Substantially Equivalent for Some Indications |
| K890054 | M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI. | Feb 8, 1989 | Substantially Equivalent for Some Indications |
| K884888 | MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS | Dec 29, 1988 | Substantially Equivalent for Some Indications |
| K882671 | SAMUELSON SCREWLOC CUP | Oct 20, 1988 | Substantially Equivalent |
| K874093 | SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP | Jan 27, 1988 | Substantially Equivalent |