The following data is part of a premarket notification filed by Folsom Metal Products, Inc. Dba Frontier Devices with the FDA for Frontier Devices Fusio Screw Fuze System.
| Device ID | K141106 |
| 510k Number | K141106 |
| Device Name: | FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM |
| Classification | Sacroiliac Joint Fixation |
| Applicant | FOLSOM METAL PRODUCTS, INC. DBA FRONTIER DEVICES 153A CAHABA VALLEY PARKWAY Pelham, AL 35124 |
| Contact | Kevin Etheridge |
| Correspondent | Kevin Etheridge FOLSOM METAL PRODUCTS, INC. DBA FRONTIER DEVICES 153A CAHABA VALLEY PARKWAY Pelham, AL 35124 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-29 |
| Decision Date | 2014-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B43690011600 | K141106 | 000 |
| B436900095350 | K141106 | 000 |
| B436900095400 | K141106 | 000 |
| B436900095450 | K141106 | 000 |
| B436900095500 | K141106 | 000 |
| B436900095550 | K141106 | 000 |
| B436900095600 | K141106 | 000 |
| B436900110 | K141106 | 000 |
| B43690011350 | K141106 | 000 |
| B43690011400 | K141106 | 000 |
| B43690011450 | K141106 | 000 |
| B43690011500 | K141106 | 000 |
| B43690011550 | K141106 | 000 |
| B4369000950 | K141106 | 000 |