The following data is part of a premarket notification filed by Link America, Inc. with the FDA for Feldmuhle Ceramic Head.
| Device ID | K920756 |
| 510k Number | K920756 |
| Device Name: | FELDMUHLE CERAMIC HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | LINK AMERICA, INC. 321 PALMER RD. Denville, NJ 07834 |
| Contact | Edward B Schussler |
| Correspondent | Edward B Schussler LINK AMERICA, INC. 321 PALMER RD. Denville, NJ 07834 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-19 |
| Decision Date | 1992-05-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026575365289 | K920756 | 000 |
| 04026575028245 | K920756 | 000 |
| 04026575028252 | K920756 | 000 |
| 04026575359080 | K920756 | 000 |
| 04026575359097 | K920756 | 000 |
| 04026575359103 | K920756 | 000 |
| 04026575365203 | K920756 | 000 |
| 04026575365210 | K920756 | 000 |
| 04026575365227 | K920756 | 000 |
| 04026575365234 | K920756 | 000 |
| 04026575365241 | K920756 | 000 |
| 04026575365258 | K920756 | 000 |
| 04026575028238 | K920756 | 000 |