The following data is part of a premarket notification filed by Baat Medical Products Bv with the FDA for Anser Clavicle Pin.
| Device ID | K201830 |
| 510k Number | K201830 |
| Device Name: | ANSER Clavicle Pin |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Baat Medical Products BV F. Hazemeijerstraat 800 - Building A04 Rj Hengelo, NL 7555 |
| Contact | Teake Bulstra |
| Correspondent | Teake Bulstra Baat Medical Products BV F. Hazemeijerstraat 800 - Building A04 Rj Hengelo, NL 7555 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-02 |
| Decision Date | 2020-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08720629950617 | K201830 | 000 |
| 08720629950600 | K201830 | 000 |
| 08720629950594 | K201830 | 000 |
| 08720629950587 | K201830 | 000 |
| 08720629950570 | K201830 | 000 |
| 08720629950563 | K201830 | 000 |
| 08720629950556 | K201830 | 000 |