The following data is part of a premarket notification filed by Kinamed Incorporated with the FDA for Iso-elastic Cerclage System (1mm And 2mm Cable Diameter).
| Device ID | K102834 |
| 510k Number | K102834 |
| Device Name: | ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER) |
| Classification | Cerclage, Fixation |
| Applicant | KINAMED INCORPORATED 820 FLYNN ROAD Camarillo, CA 93012 |
| Contact | Anthony Rose |
| Correspondent | Anthony Rose KINAMED INCORPORATED 820 FLYNN ROAD Camarillo, CA 93012 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-29 |
| Decision Date | 2011-01-12 |
| Summary: | summary |