The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Bendini(tm) Spinal Rod Bending System.
| Device ID | K111811 |
| 510k Number | K111811 |
| Device Name: | BENDINI(TM) SPINAL ROD BENDING SYSTEM |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
| Contact | Elias Ketchum |
| Correspondent | Elias Ketchum NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-27 |
| Decision Date | 2011-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517246837 | K111811 | 000 |
| 00887517141132 | K111811 | 000 |