The following data is part of a premarket notification filed by Miltex, Inc. with the FDA for Miltex Membrane Tack Kit.
| Device ID | K092855 |
| 510k Number | K092855 |
| Device Name: | MILTEX MEMBRANE TACK KIT |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | MILTEX, INC. 589 DAVIES DR. York, PA 17402 |
| Contact | Jennifer Bosley |
| Correspondent | Jennifer Bosley MILTEX, INC. 589 DAVIES DR. York, PA 17402 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-16 |
| Decision Date | 2009-12-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H834623110 | K092855 | 000 |
| H834623061 | K092855 | 000 |
| H834623000 | K092855 | 000 |
| H834623010 | K092855 | 000 |
| H834623020 | K092855 | 000 |
| H834623030 | K092855 | 000 |
| H834623040 | K092855 | 000 |
| H834623070 | K092855 | 000 |
| H834623080 | K092855 | 000 |
| H834623090 | K092855 | 000 |
| H834623100 | K092855 | 000 |
| H834623051 | K092855 | 000 |