The following data is part of a premarket notification filed by Mitek Surgical Products, Inc. with the FDA for Mitek Bone Anchor, Modification.
| Device ID | K915889 |
| 510k Number | K915889 |
| Device Name: | MITEK BONE ANCHOR, MODIFICATION |
| Classification | Staple, Fixation, Bone |
| Applicant | MITEK SURGICAL PRODUCTS, INC. 57 PROVIDENCE HWY. Norwood, MA 02062 |
| Contact | Edward F Kent |
| Correspondent | Edward F Kent MITEK SURGICAL PRODUCTS, INC. 57 PROVIDENCE HWY. Norwood, MA 02062 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-20 |
| Decision Date | 1992-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886705002174 | K915889 | 000 |