The following data is part of a premarket notification filed by Acumed Llc with the FDA for Acumed Pelvic Bone Plate System.
| Device ID | K122538 |
| 510k Number | K122538 |
| Device Name: | ACUMED PELVIC BONE PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | ACUMED LLC 5885 NW Cornelius Pass Rd Hillsboro, OR 97124 |
| Contact | Kara Budor |
| Correspondent | Kara Budor ACUMED LLC 5885 NW Cornelius Pass Rd 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 | 2012-08-21 |
| Decision Date | 2012-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10806378088605 | K122538 | 000 |
| 10806378048463 | K122538 | 000 |
| 10806378048456 | K122538 | 000 |
| 10806378048449 | K122538 | 000 |
| 10806378048432 | K122538 | 000 |
| 10806378048425 | K122538 | 000 |
| 10806378048418 | K122538 | 000 |
| 10806378048401 | K122538 | 000 |
| 10806378088568 | K122538 | 000 |
| 10806378048470 | K122538 | 000 |
| 10806378048487 | K122538 | 000 |
| 10806378088599 | K122538 | 000 |
| 10806378088582 | K122538 | 000 |
| 10806378088575 | K122538 | 000 |
| 10806378048531 | K122538 | 000 |
| 10806378048524 | K122538 | 000 |
| 10806378048517 | K122538 | 000 |
| 10806378048500 | K122538 | 000 |
| 10806378048494 | K122538 | 000 |
| 10806378088551 | K122538 | 000 |