The following data is part of a premarket notification filed by Epic Extremity, Llc with the FDA for Epic Extremity Snap-off Screw.
| Device ID | K163038 |
| 510k Number | K163038 |
| Device Name: | EPIC Extremity Snap-Off Screw |
| Classification | Screw, Fixation, Bone |
| Applicant | EPIC EXTREMITY, LLC 120 MARGUERITE DR, STE 301 Cranberry Twp, PA 16066 |
| Contact | Dan Schwartzbauer |
| Correspondent | Randy Schlemmer EPIC EXTREMITY, LLC 1000 HAMPTON CENTER SUITE A Morgantown, WV 26505 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-31 |
| Decision Date | 2017-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817577023185 | K163038 | 000 |
| 00817577023178 | K163038 | 000 |
| 00817577023161 | K163038 | 000 |
| 00817577023154 | K163038 | 000 |
| 00817577023208 | K163038 | 000 |