The following data is part of a premarket notification filed by Extremity Medical Llc with the FDA for Xmcp, Hallux, Tarsx, Extremity Medical Screw System.
| Device ID | K121417 |
| 510k Number | K121417 |
| Device Name: | XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | EXTREMITY MEDICAL LLC 300 INTERPACE PARKWAY SUITE 410 Parsippany, NJ 07054 |
| Contact | Jamy Gannoe |
| Correspondent | Jamy Gannoe EXTREMITY MEDICAL LLC 300 INTERPACE PARKWAY SUITE 410 Parsippany, NJ 07054 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-11 |
| Decision Date | 2012-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842078108208 | K121417 | 000 |
| 00842078102541 | K121417 | 000 |
| 00842078102039 | K121417 | 000 |
| 00842078102015 | K121417 | 000 |
| 00842078102008 | K121417 | 000 |
| 00842078101995 | K121417 | 000 |
| 00842078101988 | K121417 | 000 |
| 00842078101971 | K121417 | 000 |
| 00842078101957 | K121417 | 000 |
| 00842078101940 | K121417 | 000 |
| 00842078102558 | K121417 | 000 |
| 00842078102565 | K121417 | 000 |
| 00842078108154 | K121417 | 000 |
| 00842078108109 | K121417 | 000 |
| 00842078108055 | K121417 | 000 |
| 00842078102626 | K121417 | 000 |
| 00842078102619 | K121417 | 000 |
| 00842078102602 | K121417 | 000 |
| 00842078102596 | K121417 | 000 |
| 00842078102589 | K121417 | 000 |
| 00842078102572 | K121417 | 000 |
| 00842078101933 | K121417 | 000 |