The following data is part of a premarket notification filed by Orthopedic Designs North America, Inc. with the FDA for Cannulated Compression Device System.
| Device ID | K210146 |
| 510k Number | K210146 |
| Device Name: | Cannulated Compression Device System |
| Classification | Screw, Fixation, Bone |
| Applicant | Orthopedic Designs North America, Inc. 5912 Breckridge Parkway Suite F Tampa, FL 33610 |
| Contact | Robin Wilson |
| Correspondent | Robin Wilson Orthopedic Designs North America, Inc. 5912 Breckridge Parkway Suite F Tampa, FL 33610 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-21 |
| Decision Date | 2022-04-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B058CCD7516095NS1 | K210146 | 000 |
| B058CCD0915NS1 | K210146 | 000 |
| B058CCD7516045NS1 | K210146 | 000 |
| B058CCD7516050NS1 | K210146 | 000 |
| B058CCD7516055NS1 | K210146 | 000 |
| B058CCD7516060NS1 | K210146 | 000 |
| B058CCD7516065NS1 | K210146 | 000 |
| B058CCD7516070NS1 | K210146 | 000 |
| B058CCD7516075NS1 | K210146 | 000 |
| B058CCD7516080NS1 | K210146 | 000 |
| B058CCD7516085NS1 | K210146 | 000 |
| B058CCD7516090NS1 | K210146 | 000 |
| B058CCD0912NS1 | K210146 | 000 |