FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX.
K Number: K870923
·
Decision Sep 14, 1987
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
113
Applicant Total
25
Review Days
194
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Basic Information
- Device Name
- SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX.
- K Number
- K870923
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 888.3330
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Protek, Inc.
- Date Received
- March 4, 1987
- Decision Date
- September 14, 1987
- Product Code
- KWA
- 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 |
|---|---|---|---|
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | FDA class 3 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWA), ordered by most recent decision date.
PROFEMUR Z REVISION HIP STEM
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DYNASTY BIOFOAM SHELL
FDA 510(k)
FDA Class 3
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METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS
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FDA Class 3
·Orthopedic
CONSERVE THIN SHELL
FDA 510(k)
FDA Class 3
·Orthopedic
PRESERVE HIP STEM
FDA 510(k)
FDA Class 3
·Orthopedic
PROFEMUR GLADIATOR HA HIP STEM
FDA 510(k)
FDA Class 3
·Orthopedic
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 |
| K883794 | RESUBMITTED CLW ACETABULAR CUP W/SULMESH | May 26, 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 |