The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Profemur Tl2 Stems.
| Device ID | K191632 |
| 510k Number | K191632 |
| Device Name: | PROFEMUR TL2 Stems |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | MicroPort Orthopedics Inc. 5677 Airline Road Memphis, TN 38002 |
| Contact | Sneh Pingle |
| Correspondent | Sneh Pingle MicroPort Orthopedics Inc. 5677 Airline Road Memphis, 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 | 2019-06-19 |
| Decision Date | 2019-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M684PRTL2EP91 | K191632 | 000 |
| M684PRTL2EP81 | K191632 | 000 |
| M684PRTL2EP51 | K191632 | 000 |
| M684PRTL2SP91 | K191632 | 000 |
| M684PRTL2SP81 | K191632 | 000 |
| M684PRTL2SP51 | K191632 | 000 |