The following data is part of a premarket notification filed by Integra Burlington Ma, Inc. with the FDA for Integra Cusa Nxt Inferior Foward Bone Tip.
| Device ID | K113570 |
| 510k Number | K113570 |
| Device Name: | INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | INTEGRA BURLINGTON MA, INC. 22 TERRY AVE. Burlington, MA 01803 |
| Contact | Lindsay Mignone |
| Correspondent | Lindsay Mignone INTEGRA BURLINGTON MA, INC. 22 TERRY AVE. Burlington, MA 01803 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-02 |
| Decision Date | 2012-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780039495 | K113570 | 000 |