FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIMA RPS SHOULDER
K Number: K913282
·
Decision Oct 21, 1991
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
70
Applicant Total
26
Review Days
89
Basic Information
- Device Name
- LIMA RPS SHOULDER
- K Number
- K913282
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3690
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- TURNKEY INTERGRATION USA, INC.
- Date Received
- July 24, 1991
- Decision Date
- October 21, 1991
- Product Code
- HSD
- 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 |
|---|---|---|---|
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K970284 | ARTOS, DIPLOS SYSTEM | Apr 21, 1997 | Substantially Equivalent |
| K970084 | LINK CERCLAGE WIRE SYSTEM | Mar 13, 1997 | Substantially Equivalent |
| K953653 | LUBINUS SP II HIP SYSTEM | Nov 6, 1995 | Substantially Equivalent |
| K943986 | LINK ENDO MODEL REVISION CUP | Jul 5, 1995 | Substantially Equivalent |
| K951355 | LINK SADDLE PROTHESIS | May 25, 1995 | Substantially Equivalent |
| K950397 | SYSTEM 22 VALVE | Apr 14, 1995 | Substantially Equivalent |