The following data is part of a premarket notification filed by Mitek Surgical Products, Inc. with the FDA for Mitek Cancellous Fixation Screw, Cortical Fixation Screw, Soft Tissue Washer.
| Device ID | K934366 |
| 510k Number | K934366 |
| Device Name: | MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER |
| Classification | Screw, Fixation, Bone |
| Applicant | MITEK SURGICAL PRODUCTS, INC. 57 PROVIDENCE HWY. Norwood, MA 02062 |
| Contact | Robert P Zoletti |
| Correspondent | Robert P Zoletti MITEK SURGICAL PRODUCTS, INC. 57 PROVIDENCE HWY. Norwood, MA 02062 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-07 |
| Decision Date | 1994-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886705011053 | K934366 | 000 |
| 10886705007226 | K934366 | 000 |
| 10886705007233 | K934366 | 000 |
| 10886705007240 | K934366 | 000 |
| 10886705007257 | K934366 | 000 |
| 10886705007264 | K934366 | 000 |
| 10886705007271 | K934366 | 000 |
| 10886705007288 | K934366 | 000 |
| 10886705007295 | K934366 | 000 |
| 10886705007219 | K934366 | 000 |
| 10886705007202 | K934366 | 000 |
| 10886705007127 | K934366 | 000 |
| 10886705007134 | K934366 | 000 |
| 10886705007141 | K934366 | 000 |
| 10886705007158 | K934366 | 000 |
| 10886705007165 | K934366 | 000 |
| 10886705007172 | K934366 | 000 |
| 10886705007189 | K934366 | 000 |
| 10886705007196 | K934366 | 000 |
| 10886705007301 | K934366 | 000 |
| 10886705007318 | K934366 | 000 |
| 10886705007424 | K934366 | 000 |
| 10886705007431 | K934366 | 000 |
| 10886705007448 | K934366 | 000 |
| 10886705007455 | K934366 | 000 |
| 10886705007462 | K934366 | 000 |
| 10886705007479 | K934366 | 000 |
| 10886705007486 | K934366 | 000 |
| 20886705011046 | K934366 | 000 |
| 10886705007417 | K934366 | 000 |
| 10886705007400 | K934366 | 000 |
| 10886705007325 | K934366 | 000 |
| 10886705007332 | K934366 | 000 |
| 10886705007349 | K934366 | 000 |
| 10886705007356 | K934366 | 000 |
| 10886705007363 | K934366 | 000 |
| 10886705007370 | K934366 | 000 |
| 10886705007387 | K934366 | 000 |
| 10886705007394 | K934366 | 000 |
| 10886705007110 | K934366 | 000 |