The following data is part of a premarket notification filed by Nextremity Solutions, Inc. with the FDA for Arcus Staple System.
| Device ID | K151160 |
| 510k Number | K151160 |
| Device Name: | Arcus Staple System |
| Classification | Staple, Fixation, Bone |
| Applicant | NEXTREMITY SOLUTIONS, INC. 54 BROAD STREET, STE 200 Red Bank, NJ 07701 |
| Contact | Ryan Schlotterback |
| Correspondent | Ryan Schlotterback NEXTREMITY SOLUTIONS, INC. 54 BROAD STREET, STE 200 Red Bank, NJ 07701 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-01 |
| Decision Date | 2015-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817701020219 | K151160 | 000 |
| 00817701020127 | K151160 | 000 |
| 00817701020134 | K151160 | 000 |
| 00817701020141 | K151160 | 000 |
| 00817701020158 | K151160 | 000 |
| 00817701020165 | K151160 | 000 |
| 00817701020172 | K151160 | 000 |
| 00817701020189 | K151160 | 000 |
| 00817701020196 | K151160 | 000 |
| 00817701020202 | K151160 | 000 |
| 00817701020110 | K151160 | 000 |