The following data is part of a premarket notification filed by In2bonesusa, Llc with the FDA for Neospan Compression Staple Impant W/instruments.
| Device ID | K161426 |
| 510k Number | K161426 |
| Device Name: | NeoSpan Compression Staple Impant W/instruments |
| Classification | Staple, Fixation, Bone |
| Applicant | IN2BONESUSA, LLC 6060 POPLAR AVE, SUITE 380 Memphis, TN 38119 |
| Contact | Joe Clift |
| Correspondent | Louise Focht ENMED INTERNATIONAL, INC PO BOX 249 Del Mar, CA 92014 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-23 |
| Decision Date | 2016-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817906020182 | K161426 | 000 |
| 00810021861371 | K161426 | 000 |
| 00817906020076 | K161426 | 000 |
| 00817906020083 | K161426 | 000 |
| 00817906020090 | K161426 | 000 |
| 00817906020106 | K161426 | 000 |
| 00817906020113 | K161426 | 000 |
| 00817906020120 | K161426 | 000 |
| 00817906020137 | K161426 | 000 |
| 00817906020144 | K161426 | 000 |
| 00817906020151 | K161426 | 000 |
| 00817906020168 | K161426 | 000 |
| 00817906020175 | K161426 | 000 |
| 00810021861364 | K161426 | 000 |