BIOBOLT
Fastener, Fixation, Biodegradable, Soft Tissue
ARTHREX, INC.
The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Biobolt.
Pre-market Notification Details
| Device ID | K120540 |
| 510k Number | K120540 |
| Device Name: | BIOBOLT |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Courtney Smith |
| Correspondent | Courtney Smith ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-23 |
| Decision Date | 2012-03-20 |
| Summary: | summary |
Trademark Results [BIOBOLT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOBOLT 77887496 not registered Dead/Abandoned |
U.S. Implant Technologies Inc 2009-12-07 |
 BIOBOLT 77887100 not registered Dead/Abandoned |
Arthrex, Inc. 2009-12-06 |
 BIOBOLT 77674079 3698143 Dead/Cancelled |
Intelligent Biometric Controls, Inc. 2009-02-19 |
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