The following data is part of a premarket notification filed by Acumed Llc with the FDA for Acumed Lower Extremity Congruent Plate System.
| Device ID | K033639 |
| 510k Number | K033639 |
| Device Name: | ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro, OR 97124 -9432 |
| Contact | Ed Boehmer |
| Correspondent | Ed Boehmer ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro, OR 97124 -9432 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-20 |
| Decision Date | 2004-01-15 |
| Summary: | summary |