The following data is part of a premarket notification filed by Extremity Medical, Llc with the FDA for Extremity Medical Ip Fusion System.
| Device ID | K130120 |
| 510k Number | K130120 |
| Device Name: | EXTREMITY MEDICAL IP FUSION SYSTEM |
| 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 | 2013-01-17 |
| Decision Date | 2013-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842078109304 | K130120 | 000 |
| 00842078108376 | K130120 | 000 |
| 00842078108383 | K130120 | 000 |
| 00842078108390 | K130120 | 000 |
| 00842078108406 | K130120 | 000 |
| 00842078108413 | K130120 | 000 |
| 00842078108420 | K130120 | 000 |
| 00842078108437 | K130120 | 000 |
| 00842078108611 | K130120 | 000 |
| 00842078108635 | K130120 | 000 |
| 00842078108895 | K130120 | 000 |
| 00842078108918 | K130120 | 000 |
| 00842078108963 | K130120 | 000 |
| 00842078108987 | K130120 | 000 |
| 00842078109281 | K130120 | 000 |
| 00842078108369 | K130120 | 000 |