| Primary Device ID | M695M1901000S0 |
| NIH Device Record Key | e004dc7f-aff8-4652-8800-4ff78675b2cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FuseFix Hammertoe |
| Version Model Number | M19-01000-S |
| Catalog Number | M19-01000-S |
| Company DUNS | 010968002 |
| Company Name | Tyber Medical LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M695M1901000S0 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-13 |
| Device Publish Date | 2020-01-03 |
| M695M1901011S0 | Mini Fixed AO Handle w/ Ø1.1mm Guidewire (6”) Kit |
| M695M1901009S0 | Mini Fixed AO Handle w/ Ø0.9mm Guidewire (6”) Kit |
| M695M1901000S0 | Mini Fixed AO Handle |
| M695M13S30115S0 | FuseFix Solid 10° Ø3.0mm x 15mm |
| M695M13S30015S0 | FuseFix Solid 0° Ø3.0mm x 15mm |
| M695M13S25115S0 | FuseFix Solid 10° Ø2.5mm x 15mm |
| M695M13S25115D0 | Demo FuseFix Solid 10° Ø2.5mm x 15mm |
| M695M13S25015S0 | FuseFix Solid 0° Ø2.5mm x 15mm |
| M695M13S25015D0 | Demo FuseFix Solid 0° Ø2.5mm x 15mm |
| M695M13S20113S0 | FuseFix Solid 10° Ø2.0mm x 13mm |
| M695M13S20013S0 | FuseFix Solid 0° Ø2.0mm x 13mm |
| M695M13C30015S0 | FuseFix Cannulated Ø3.0mm x 15mm |
| M695M13C25015S0 | FuseFix Cannulated Ø2.5mm x 15mm |
| M695M13C25015D0 | Demo FuseFix Cannulated Ø2.5mm x 15mm |
| M695M13C20013S0 | FuseFix Cannulated Ø2.0mm x 13mm |