The following data is part of a premarket notification filed by Medacta International with the FDA for Mectacer Biolox(r) Delta Femoral Heads.
| Device ID | K112115 |
| 510k Number | K112115 |
| Device Name: | MECTACER BIOLOX(R) DELTA FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012 |
| Contact | Adam Gross |
| Correspondent | Adam Gross MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-25 |
| Decision Date | 2011-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030809309 | K112115 | 000 |
| 07630030809132 | K112115 | 000 |
| 07630030809149 | K112115 | 000 |
| 07630030809156 | K112115 | 000 |
| 07630030809163 | K112115 | 000 |
| 07630030809170 | K112115 | 000 |
| 07630030809187 | K112115 | 000 |
| 07630030809194 | K112115 | 000 |
| 07630030809200 | K112115 | 000 |
| 07630030809217 | K112115 | 000 |
| 07630030809224 | K112115 | 000 |
| 07630030809231 | K112115 | 000 |
| 07630030809248 | K112115 | 000 |
| 07630030809255 | K112115 | 000 |
| 07630030809262 | K112115 | 000 |
| 07630030809279 | K112115 | 000 |
| 07630030809286 | K112115 | 000 |
| 07630030809293 | K112115 | 000 |
| 07630030809125 | K112115 | 000 |