FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LINK CERAMIC HEADS 14/16 X 32MM
K Number: K931572
·
Decision Mar 28, 1994
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
530
Applicant Total
21
Review Days
363
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Basic Information
- Device Name
- LINK CERAMIC HEADS 14/16 X 32MM
- K Number
- K931572
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Link America, Inc.
- Date Received
- March 30, 1993
- Decision Date
- March 28, 1994
- Product Code
- LZO
- 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 |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | FDA class 2 | Orthopedic |
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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 |
| K954186 | SLED UNICOMPARTMENT KNEE SYSTEM | Jan 26, 1996 | Substantially Equivalent |
| K931571 | LINK CERAMIC HEADS 12/14 X 32MM | Apr 19, 1994 | Substantially Equivalent for Some Indications |
| 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 |