The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Integra Digifuse Cannulated Intramedullary Fusion System,integra Total Foot System,integra Capture Screw System & Integra Ti6 Internal Fixation System,subtalar Mba System,metasurg Subtalar Implant,newdeal Bold Screw,newdeal Hallu Lock Plate System,ne.
| Device ID | K210016 |
| 510k Number | K210016 |
| Device Name: | Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,Ne |
| Classification | Plate, Fixation, Bone |
| Applicant | Integra Lifesciences Corporation 11101 Metric Blvd Austin, TX 78758 |
| Contact | Blesson Abraham |
| Correspondent | Nichole Mendiola Integra Lifesciences Corporation 11101 Metric Blvd Austin, TX 78758 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-04 |
| Decision Date | 2021-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556865910 | K210016 | 000 |
| 00885556865903 | K210016 | 000 |
| 00885556865897 | K210016 | 000 |
| 00885556865880 | K210016 | 000 |
| 00885556865873 | K210016 | 000 |