The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Biolox Delta Option And Extra-long Heads.
| Device ID | K173776 |
| 510k Number | K173776 |
| Device Name: | BIOLOX Delta Option And Extra-long Heads |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | MicroPort Orthopedics Inc. 5677 Airline Road Arlington, TN 38002 |
| Contact | Allen Mamaril |
| Correspondent | Allen Mamaril MicroPort Orthopedics Inc. 5677 Airline Road Arlington, TN 38002 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-12 |
| Decision Date | 2018-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M684PHA044441 | K173776 | 000 |
| M684PHA044401 | K173776 | 000 |
| M684PHA044361 | K173776 | 000 |
| M684PHA044321 | K173776 | 000 |
| M684PHA044281 | K173776 | 000 |
| M684PHA044261 | K173776 | 000 |
| M684PHA044191 | K173776 | 000 |
| M684PHA044131 | K173776 | 000 |