The following data is part of a premarket notification filed by Rsb Spine Llc. with the FDA for Interplate Peek Cervical Interbody Fusion Device (ifd).
| Device ID | K081194 |
| 510k Number | K081194 |
| Device Name: | INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD) |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | RSB SPINE LLC. 8202 SHERMAN ROAD Chesterland, OH 44026 |
| Contact | Karen E Warden |
| Correspondent | Karen E Warden RSB SPINE LLC. 8202 SHERMAN ROAD Chesterland, OH 44026 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-28 |
| Decision Date | 2008-05-29 |
| Summary: | summary |