The following data is part of a premarket notification filed by Cycla Orthopedics Ltd with the FDA for Cyclaplex Correction System.
| Device ID | K183094 |
| 510k Number | K183094 |
| Device Name: | CyclaPlex Correction System |
| Classification | Washer, Bolt Nut |
| Applicant | Cycla Orthopedics Ltd 14 Hame Yasdim St. Bat Shlomo, IL 30992 |
| Contact | Rafi Herzog |
| Correspondent | Elaine Duncan Paladin Medical PO Box 560 Stilwater, MN 55082 -0560 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-07 |
| Decision Date | 2019-04-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290017626222 | K183094 | 000 |
| 07290017626192 | K183094 | 000 |
| 07290017626161 | K183094 | 000 |
| 07290017626123 | K183094 | 000 |
| 07290017626116 | K183094 | 000 |
| 07290017626826 | K183094 | 000 |