The following data is part of a premarket notification filed by Acumed Llc with the FDA for Congruent Bone Plate System: Acu-loc 2 Plate.
| Device ID | K120903 |
| 510k Number | K120903 |
| Device Name: | CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro, OR 97124 -9432 |
| Contact | Brittany Cunningham |
| Correspondent | Brittany Cunningham ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro, OR 97124 -9432 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-26 |
| Decision Date | 2012-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10806378045776 | K120903 | 000 |
| 10806378045769 | K120903 | 000 |
| 10806378044472 | K120903 | 000 |
| 10806378044465 | K120903 | 000 |
| 10806378044458 | K120903 | 000 |
| 10806378041310 | K120903 | 000 |
| 10806378041303 | K120903 | 000 |
| 10806378041297 | K120903 | 000 |
| 10806378015632 | K120903 | 000 |