The following data is part of a premarket notification filed by Camber Spine Technologies Llc with the FDA for Orthros™ Posterior Stabilization System; Orthros™ Mis Posterior Stabilization System.
| Device ID | K180980 |
| 510k Number | K180980 |
| Device Name: | ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Camber Spine Technologies LLC 418 E. Lancaster Ave. Wayne, PA 19087 |
| Contact | Tom Zamorski |
| Correspondent | Manjusha Bharadwaj RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, MA 01913 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-13 |
| Decision Date | 2018-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B030ORM7555L0 | K180980 | 000 |
| B030ORM751100 | K180980 | 000 |
| B030ORM75105L0 | K180980 | 000 |
| B030ORM751050 | K180980 | 000 |
| B030ORM75100L0 | K180980 | 000 |
| B030ORM751000 | K180980 | 000 |
| B030ORM6565L0 | K180980 | 000 |
| B030ORM65650 | K180980 | 000 |
| B030ORM6560L0 | K180980 | 000 |
| B030ORM65600 | K180980 | 000 |
| B030ORM6555L0 | K180980 | 000 |
| B030ORM75110L0 | K180980 | 000 |
| B030ORM75300 | K180980 | 000 |
| B030ORM75550 | K180980 | 000 |
| B030ORM7550L0 | K180980 | 000 |
| B030ORM75500 | K180980 | 000 |
| B030ORM7545L0 | K180980 | 000 |
| B030ORM75450 | K180980 | 000 |
| B030ORM7540L0 | K180980 | 000 |
| B030ORM75400 | K180980 | 000 |
| B030ORM7535L0 | K180980 | 000 |
| B030ORM75350 | K180980 | 000 |
| B030ORM7530L0 | K180980 | 000 |
| B030ORM65550 | K180980 | 000 |
| B030ORM6550L0 | K180980 | 000 |
| B030ORM65500 | K180980 | 000 |
| B030ORM5545L0 | K180980 | 000 |
| B030ORM55450 | K180980 | 000 |
| B030ORM5540L0 | K180980 | 000 |
| B030ORM55400 | K180980 | 000 |
| B030ORM5535L0 | K180980 | 000 |
| B030ORM55350 | K180980 | 000 |
| B030ORM5530L0 | K180980 | 000 |
| B030ORM55300 | K180980 | 000 |
| B030ORM5525L0 | K180980 | 000 |
| B030ORM55250 | K180980 | 000 |
| B030ORM55500 | K180980 | 000 |
| B030ORM5550L0 | K180980 | 000 |
| B030ORM6545L0 | K180980 | 000 |
| B030ORM65450 | K180980 | 000 |
| B030ORM6540L0 | K180980 | 000 |
| B030ORM65400 | K180980 | 000 |
| B030ORM6535L0 | K180980 | 000 |
| B030ORM65350 | K180980 | 000 |
| B030ORM6530L0 | K180980 | 000 |
| B030ORM65300 | K180980 | 000 |
| B030ORM5555L0 | K180980 | 000 |
| B030ORM55550 | K180980 | 000 |
| B030CM002100 | K180980 | 000 |
| B030ORM75600 | K180980 | 000 |
| B030ORM8595L0 | K180980 | 000 |
| B030ORM85650 | K180980 | 000 |
| B030ORM8560L0 | K180980 | 000 |
| B030ORM85600 | K180980 | 000 |
| B030ORM8555L0 | K180980 | 000 |
| B030ORM85550 | K180980 | 000 |
| B030ORM8550L0 | K180980 | 000 |
| B030ORM85500 | K180980 | 000 |
| B030ORM8545L0 | K180980 | 000 |
| B030ORM85450 | K180980 | 000 |
| B030ORM8540L0 | K180980 | 000 |
| B030ORM8565L0 | K180980 | 000 |
| B030ORM85700 | K180980 | 000 |
| B030ORM85950 | K180980 | 000 |
| B030ORM8590L0 | K180980 | 000 |
| B030ORM85900 | K180980 | 000 |
| B030ORM8585L0 | K180980 | 000 |
| B030ORM85850 | K180980 | 000 |
| B030ORM8580L0 | K180980 | 000 |
| B030ORM85800 | K180980 | 000 |
| B030ORM8575L0 | K180980 | 000 |
| B030ORM85750 | K180980 | 000 |
| B030ORM8570L0 | K180980 | 000 |
| B030ORM85400 | K180980 | 000 |
| B030ORM8535L0 | K180980 | 000 |
| B030ORM85350 | K180980 | 000 |
| B030ORM7585L0 | K180980 | 000 |
| B030ORM75850 | K180980 | 000 |
| B030ORM7580L0 | K180980 | 000 |
| B030ORM75800 | K180980 | 000 |
| B030ORM7575L0 | K180980 | 000 |
| B030ORM75750 | K180980 | 000 |
| B030ORM7570L0 | K180980 | 000 |
| B030ORM75700 | K180980 | 000 |
| B030ORM7565L0 | K180980 | 000 |
| B030ORM75650 | K180980 | 000 |
| B030ORM75900 | K180980 | 000 |
| B030ORM7590L0 | K180980 | 000 |
| B030ORM8530L0 | K180980 | 000 |
| B030ORM85300 | K180980 | 000 |
| B030ORM85110L0 | K180980 | 000 |
| B030ORM851100 | K180980 | 000 |
| B030ORM85105L0 | K180980 | 000 |
| B030ORM851050 | K180980 | 000 |
| B030ORM85100L0 | K180980 | 000 |
| B030ORM851000 | K180980 | 000 |
| B030ORM7595L0 | K180980 | 000 |
| B030ORM75950 | K180980 | 000 |
| B030ORM7560L0 | K180980 | 000 |