The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Isola Polyaxial Washer.
| Device ID | K013441 |
| 510k Number | K013441 |
| Device Name: | ISOLA POLYAXIAL WASHER |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Lisa Gilman |
| Correspondent | Lisa Gilman DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-17 |
| Decision Date | 2001-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034226880 | K013441 | 000 |
| 10705034226873 | K013441 | 000 |
| 10705034226866 | K013441 | 000 |