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 |