The following data is part of a premarket notification filed by Geny Medical, Inc. with the FDA for Mini-h-fixation.
| Device ID | K792561 |
| 510k Number | K792561 |
| Device Name: | MINI-H-FIXATION |
| Classification | Component, Traction, Invasive |
| Applicant | GENY MEDICAL, INC. 66 ARGONAUT # 170 Aliso Viejo, CA 92656 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-12 |
| Decision Date | 1979-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327079784 | K792561 | 000 |
| 07613327079746 | K792561 | 000 |
| 07613327079708 | K792561 | 000 |
| 07613327079692 | K792561 | 000 |
| 07613327079685 | K792561 | 000 |
| 07613327079678 | K792561 | 000 |
| 07613327079661 | K792561 | 000 |