The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Integra Titan Reverse Shoulder System.
| Device ID | K181999 |
| 510k Number | K181999 |
| Device Name: | Integra TITAN Reverse Shoulder System |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | Integra Lifesciences Corporation 11101 Metric Blvd. Austin, TX 78758 |
| Contact | Blesson Abraham |
| Correspondent | Blesson Abraham Integra Lifesciences Corporation 11101 Metric Blvd. Austin, TX 78758 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-26 |
| Decision Date | 2018-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556864401 | K181999 | 000 |
| 00885556863794 | K181999 | 000 |
| 00885556863800 | K181999 | 000 |
| 00885556863817 | K181999 | 000 |
| 00885556863824 | K181999 | 000 |
| 00885556864418 | K181999 | 000 |
| 00885556864425 | K181999 | 000 |
| 10381780489177 | K181999 | 000 |
| 00885556864432 | K181999 | 000 |
| 00885556864449 | K181999 | 000 |
| 00885556864456 | K181999 | 000 |
| 00885556864463 | K181999 | 000 |
| 00885556864470 | K181999 | 000 |
| 00885556864487 | K181999 | 000 |
| 00885556860281 | K181999 | 000 |