The following data is part of a premarket notification filed by Rsb Spine Llc. with the FDA for C-ps Peek Optima Cervical Interbody Spacer, L-ps Peek Optima Lumbar Interbody Spacer.
| Device ID | K092540 |
| 510k Number | K092540 |
| Device Name: | C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | RSB SPINE LLC. 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
| Contact | Karen Warden |
| Correspondent | Karen Warden RSB SPINE LLC. 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-19 |
| Decision Date | 2010-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M69601CPS010 | K092540 | 000 |
| M696CPS604S0 | K092540 | 000 |
| M696CPS605S0 | K092540 | 000 |
| M696CPS606S0 | K092540 | 000 |
| M696CPS607S0 | K092540 | 000 |
| M696CPS608S0 | K092540 | 000 |
| M696CPS609S0 | K092540 | 000 |
| M696CPS610S0 | K092540 | 000 |
| M696CPS620S0 | K092540 | 000 |
| 00817893020004 | K092540 | 000 |
| 00817893020011 | K092540 | 000 |
| 00817893020028 | K092540 | 000 |
| 00817893020035 | K092540 | 000 |
| M696CPS603S0 | K092540 | 000 |
| M696CPS602S0 | K092540 | 000 |
| M696CPS601S0 | K092540 | 000 |
| M69601CPS020 | K092540 | 000 |
| M696CPS0612S0 | K092540 | 000 |
| M696CPS0615S0 | K092540 | 000 |
| M696CPS0712S0 | K092540 | 000 |
| M696CPS0715S0 | K092540 | 000 |
| M696CPS0812S0 | K092540 | 000 |
| M696CPS0815S0 | K092540 | 000 |
| M696CPS0912S0 | K092540 | 000 |
| M696CPS0915S0 | K092540 | 000 |
| M696CPS1012S0 | K092540 | 000 |
| M696CPS1015S0 | K092540 | 000 |
| M696CPS600S0 | K092540 | 000 |
| 00817893020042 | K092540 | 000 |
| 00817893020059 | K092540 | 000 |
| 00817893020066 | K092540 | 000 |
| 00817893020912 | K092540 | 000 |
| 00817893020929 | K092540 | 000 |
| 00817893020936 | K092540 | 000 |
| 00817893020943 | K092540 | 000 |
| 00817893020950 | K092540 | 000 |
| 00817893020967 | K092540 | 000 |
| 00817893021193 | K092540 | 000 |
| 00817893021209 | K092540 | 000 |
| 00817893021254 | K092540 | 000 |
| 00817893021278 | K092540 | 000 |
| 00817893021292 | K092540 | 000 |
| 00817893021308 | K092540 | 000 |
| 00817893020905 | K092540 | 000 |
| 00817893020899 | K092540 | 000 |
| 00817893020882 | K092540 | 000 |
| 00817893020073 | K092540 | 000 |
| 00817893020080 | K092540 | 000 |
| 00817893020097 | K092540 | 000 |
| 00817893020103 | K092540 | 000 |
| 00817893020110 | K092540 | 000 |
| 00817893020127 | K092540 | 000 |
| 00817893020134 | K092540 | 000 |
| 00817893020240 | K092540 | 000 |
| 00817893020257 | K092540 | 000 |
| 00817893020851 | K092540 | 000 |
| 00817893020868 | K092540 | 000 |
| 00817893020875 | K092540 | 000 |
| 00817893021315 | K092540 | 000 |