The following data is part of a premarket notification filed by Ascension Orthopedics, Inc. with the FDA for Ascension Pyrocarbon Lunate.
| Device ID | K080997 |
| 510k Number | K080997 |
| Device Name: | ASCENSION PYROCARBON LUNATE |
| Classification | Prosthesis, Wrist, Carpal Lunate |
| 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 | KWN |
| CFR Regulation Number | 888.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-08 |
| Decision Date | 2008-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556858769 | K080997 | 000 |
| M269TRL71501T1 | K080997 | 000 |
| M269TRL71502T1 | K080997 | 000 |
| M269TRL71503T1 | K080997 | 000 |
| M269TRL71504T1 | K080997 | 000 |
| M269TRL71505T1 | K080997 | 000 |
| 10381780116240 | K080997 | 000 |
| 10381780116257 | K080997 | 000 |
| 10381780116264 | K080997 | 000 |
| 10381780116271 | K080997 | 000 |
| 10381780116288 | K080997 | 000 |
| 00885556858721 | K080997 | 000 |
| 00885556858738 | K080997 | 000 |
| 00885556858745 | K080997 | 000 |
| 00885556858752 | K080997 | 000 |
| M268PYROLUNINSTP1 | K080997 | 000 |