The following data is part of a premarket notification filed by Tissue Regeneration Systems, Inc. with the FDA for Trs Cranial Bone Void Filler(trs C-bvf).
| Device ID | K123633 |
| 510k Number | K123633 |
| Device Name: | TRS CRANIAL BONE VOID FILLER(TRS C-BVF) |
| Classification | Cover, Burr Hole |
| Applicant | TISSUE REGENERATION SYSTEMS, INC. 5400 CARILLON POINT Kirkland, WA 98033 |
| Contact | Jim Fitzsimmons |
| Correspondent | Jim Fitzsimmons TISSUE REGENERATION SYSTEMS, INC. 5400 CARILLON POINT Kirkland, WA 98033 |
| Product Code | GXR |
| CFR Regulation Number | 882.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-23 |
| Decision Date | 2013-08-16 |
| Summary: | summary |