The following data is part of a premarket notification filed by Zimmer Spine, Inc. with the FDA for Zimmer Dto Pin Press Instrument.
| Device ID | K101704 |
| 510k Number | K101704 |
| Device Name: | ZIMMER DTO PIN PRESS INSTRUMENT |
| Classification | Posterior Metal/polymer Spinal System, Fusion |
| Applicant | ZIMMER SPINE, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 |
| Contact | Tim Crabtree |
| Correspondent | Tim Crabtree ZIMMER SPINE, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 |
| Product Code | NQP |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-17 |
| Decision Date | 2010-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024284456 | K101704 | 000 |