FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SLED UNICOMPARTMENT KNEE SYSTEM
K Number: K954186
·
Decision Jan 26, 1996
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
113
Applicant Total
21
Review Days
142
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SLED UNICOMPARTMENT KNEE SYSTEM
- K Number
- K954186
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3520
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Link America, Inc.
- Date Received
- September 6, 1995
- Decision Date
- January 26, 1996
- Product Code
- HSX
- 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 |
|---|---|---|---|
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HSX), ordered by most recent decision date.
Tahoe Unicondylar Knee System with TiNbN Overcoat
FDA 510(k)
FDA Class 2
·Orthopedic
Cambridge Partial Knee
FDA 510(k)
FDA Class 2
·Orthopedic
Persona Partial Knee
FDA 510(k)
FDA Class 2
·Orthopedic
MOTO Partial Knee System Extension
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex iBalance Partial Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
ACTIFY Unicondylar Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Link America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972760 | LINK, ACETABULAR REVISION MESH CUP | Oct 22, 1997 | Substantially Equivalent |
| K964458 | ELLIS EXTERNAL MINI-FIXATOR SYSTEM | Dec 9, 1996 | Substantially Equivalent |
| K955296 | LINK MP RECONSTRUCTION HIP | Feb 14, 1996 | Substantially Equivalent |
| K931571 | LINK CERAMIC HEADS 12/14 X 32MM | Apr 19, 1994 | Substantially Equivalent for Some Indications |
| K931572 | LINK CERAMIC HEADS 14/16 X 32MM | Mar 28, 1994 | Substantially Equivalent |
| K920756 | FELDMUHLE CERAMIC HEAD | May 18, 1992 | Substantially Equivalent |
| K914804 | RADIUS OSTEOTOMY PLATES | Apr 29, 1992 | Substantially Equivalent for Some Indications |
| K914803 | SCHWABE RADIUS PLATES | Apr 28, 1992 | Substantially Equivalent |
| K895507 | LINK GIEBEL BLADE PLATE SYSTEM | Mar 13, 1990 | Substantially Equivalent |
| K873507 | LINK (R) AMERICAN-TYPE BONE STAPLE SYSTEM | Sep 16, 1987 | Substantially Equivalent |