The following data is part of a premarket notification filed by Orthotec,llc with the FDA for Scs Claris Spinal System,rextended Omniaxial Connector-,medium, Model Co05, Scs Claris Spinal System,extended Omniaxialo.
| Device ID | K021919 |
| 510k Number | K021919 |
| Device Name: | SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | ORTHOTEC,LLC 8202 SHERMAN RD. Chesterland, OH 44026 -2141 |
| Contact | Karen E Warden |
| Correspondent | Karen E Warden ORTHOTEC,LLC 8202 SHERMAN RD. Chesterland, OH 44026 -2141 |
| Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-11 |
| Decision Date | 2002-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840996122924 | K021919 | 000 |
| 00840996122917 | K021919 | 000 |