The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+.
| Device ID | K123982 |
| 510k Number | K123982 |
| Device Name: | TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+ |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Michaela Norris |
| Correspondent | Michaela Norris ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-26 |
| Decision Date | 2013-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912145404 | K123982 | 000 |
| 00888912145060 | K123982 | 000 |
| 00888912145046 | K123982 | 000 |
| 00888912145039 | K123982 | 000 |
| 00888912024938 | K123982 | 000 |
| 00888912145107 | K123982 | 000 |
| 00888912024976 | K123982 | 000 |
| 00888912024969 | K123982 | 000 |
| 00888912024952 | K123982 | 000 |
| 00888912145084 | K123982 | 000 |
| 00888912025096 | K123982 | 000 |
| 00888912145381 | K123982 | 000 |
| 00888912145374 | K123982 | 000 |
| 00888912145367 | K123982 | 000 |
| 00888912145350 | K123982 | 000 |
| 00888912145343 | K123982 | 000 |
| 00888912145329 | K123982 | 000 |
| 00888912145312 | K123982 | 000 |
| 00888912145305 | K123982 | 000 |
| 00888912024945 | K123982 | 000 |