The following data is part of a premarket notification filed by Integra Burlington Ma, Inc. (formerly Integra Radi with the FDA for Integra(tm) Cusa Nxt(tm) Bone Tips.
| Device ID | K111741 |
| 510k Number | K111741 |
| Device Name: | INTEGRA(TM) CUSA NXT(TM) BONE TIPS |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | INTEGRA BURLINGTON MA, INC. (FORMERLY INTEGRA RADI 22 Terry Ave Burlington, MA 01803 |
| Contact | Kevin J O'connell |
| Correspondent | Kevin J O'connell INTEGRA BURLINGTON MA, INC. (FORMERLY INTEGRA RADI 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 | 2011-06-21 |
| Decision Date | 2011-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780039471 | K111741 | 000 |
| M269NXT3218EA1 | K111741 | 000 |