The following data is part of a premarket notification filed by Ascension Orthopedics, Inc. with the FDA for Ascension Silicone Pip.
| Device ID | K082231 |
| 510k Number | K082231 |
| Device Name: | ASCENSION SILICONE PIP |
| Classification | Prosthesis, Finger, Constrained, Polymer |
| Applicant | ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin, TX 78754 -3832 |
| Contact | Debbie Stearns |
| Correspondent | Debbie Stearns ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin, TX 78754 -3832 |
| Product Code | KYJ |
| CFR Regulation Number | 888.3230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-07 |
| Decision Date | 2009-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556858493 | K082231 | 000 |
| 00885556858615 | K082231 | 000 |
| 00885556858622 | K082231 | 000 |
| 00885556858639 | K082231 | 000 |
| 00885556858646 | K082231 | 000 |
| 00885556858653 | K082231 | 000 |
| 00885556858660 | K082231 | 000 |
| 00885556858677 | K082231 | 000 |
| 00885556858684 | K082231 | 000 |
| 00885556858691 | K082231 | 000 |
| 00885556858608 | K082231 | 000 |
| 00885556858592 | K082231 | 000 |
| 00885556858509 | K082231 | 000 |
| 00885556858516 | K082231 | 000 |
| 00885556858523 | K082231 | 000 |
| 00885556858530 | K082231 | 000 |
| 00885556858547 | K082231 | 000 |
| 00885556858554 | K082231 | 000 |
| 00885556858561 | K082231 | 000 |
| 00885556858578 | K082231 | 000 |
| 00885556858585 | K082231 | 000 |
| M268PYROPIPINSTP1 | K082231 | 000 |
| M268SILPIPINSTP1 | K082231 | 000 |
| M269TRL20230D1 | K082231 | 000 |
| M269TRL20230P1 | K082231 | 000 |
| M269TRL20240D1 | K082231 | 000 |
| M269TRL52001 | K082231 | 000 |
| M269TRL52011 | K082231 | 000 |
| M269TRL52021 | K082231 | 000 |
| M269TRL52031 | K082231 | 000 |
| M269TRL52041 | K082231 | 000 |
| M269TRL52051 | K082231 | 000 |
| M269TRL20220D1 | K082231 | 000 |
| M269TRL20240P1 | K082231 | 000 |
| 10381780116295 | K082231 | 000 |
| 10381780116301 | K082231 | 000 |
| 10381780116318 | K082231 | 000 |
| 10381780116325 | K082231 | 000 |
| 10381780116332 | K082231 | 000 |
| 10381780116349 | K082231 | 000 |
| M269TRL20220P1 | K082231 | 000 |
| M269TRL20210D1 | K082231 | 000 |
| M269TRL20210P1 | K082231 | 000 |
| M269TMP200011 | K082231 | 000 |