The following data is part of a premarket notification filed by Extremity Medical, Llc. with the FDA for Extremity Medical Hammertoe Device.
| Device ID | K133636 |
| 510k Number | K133636 |
| Device Name: | EXTREMITY MEDICAL HAMMERTOE DEVICE |
| Classification | Screw, Fixation, Bone |
| Applicant | EXTREMITY MEDICAL, LLC. 300 INTERPACE PKWY, STE 410 Parsippany, NJ 07054 |
| Contact | Brian Smekal |
| Correspondent | Brian Smekal EXTREMITY MEDICAL, LLC. 300 INTERPACE PKWY, STE 410 Parsippany, NJ 07054 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-26 |
| Decision Date | 2014-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842078100066 | K133636 | 000 |
| 00842078100059 | K133636 | 000 |
| 00842078100042 | K133636 | 000 |