The following data is part of a premarket notification filed by Rsb Spine Llc. with the FDA for Interplate C.
Device ID | K092070 |
510k Number | K092070 |
Device Name: | INTERPLATE C |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
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 | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-07-08 |
Decision Date | 2009-10-06 |
Summary: | summary |