The following data is part of a premarket notification filed by Rsb Spine Llc. with the FDA for Modification To: Interplate Vbr System.
Device ID | K071372 |
510k Number | K071372 |
Device Name: | MODIFICATION TO: INTERPLATE VBR SYSTEM |
Classification | Spinal Vertebral Body Replacement Device |
Applicant | RSB SPINE LLC. 8202 SHERMAN ROAD Chesterland, OH 44026 |
Contact | Karen Warden |
Correspondent | Karen Warden RSB SPINE LLC. 8202 SHERMAN ROAD Chesterland, OH 44026 |
Product Code | MQP |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-05-16 |
Decision Date | 2007-06-11 |
Summary: | summary |