The following data is part of a premarket notification filed by Link America, Inc. with the FDA for Link Ceramic Heads 12/14 X 32mm.
| Device ID | K931571 |
| 510k Number | K931571 |
| Device Name: | LINK CERAMIC HEADS 12/14 X 32MM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | LINK AMERICA, INC. 321 PALMER RD. Denville, NJ 07834 |
| Contact | Jonathan Martinek |
| Correspondent | Jonathan Martinek LINK AMERICA, INC. 321 PALMER RD. Denville, NJ 07834 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-30 |
| Decision Date | 1994-04-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026575028283 | K931571 | 000 |
| 04026575028276 | K931571 | 000 |
| 04026575028269 | K931571 | 000 |