The following data is part of a premarket notification filed by Acumed Llc with the FDA for Acumed Clavicle Hook Plating System.
| Device ID | K210750 |
| 510k Number | K210750 |
| Device Name: | Acumed Clavicle Hook Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | Acumed LLC 5885 NE Cornelius Pass Road Hillsboro, OR 97124 |
| Contact | Janki Bhatt |
| Correspondent | Janki Bhatt Acumed LLC 5885 NE Cornelius Pass Road Hillsboro, OR 97124 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-12 |
| Decision Date | 2021-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10806378117244 | K210750 | 000 |
| 10806378117367 | K210750 | 000 |
| 10806378117374 | K210750 | 000 |
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| 10806378117671 | K210750 | 000 |
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| 10806378117572 | K210750 | 000 |
| 10806378117589 | K210750 | 000 |
| 10806378117596 | K210750 | 000 |
| 10806378117718 | K210750 | 000 |