The following data is part of a premarket notification filed by Ascension Orthopedics with the FDA for Integra Titan Modular Total Shoulder System Fin-lock Glenoid.
| Device ID | K152047 |
| 510k Number | K152047 |
| Device Name: | INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | ASCENSION ORTHOPEDICS 8700 CAMERON ROAD, SUITE 100 Austin, TX 78754 |
| Contact | William Garzon |
| Correspondent | William Garzon ASCENSION ORTHOPEDICS 8700 CAMERON ROAD, SUITE 100 Austin, TX 78754 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-23 |
| Decision Date | 2015-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M269GLN092603003A1 | K152047 | 000 |
| M269GLN092603002A1 | K152047 | 000 |
| M269GLN092603001A1 | K152047 | 000 |
| M269GLN092603000A1 | K152047 | 000 |
| 00885556860335 | K152047 | 000 |
| 00885556860328 | K152047 | 000 |
| 00885556860311 | K152047 | 000 |
| 00885556860304 | K152047 | 000 |