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 |