The following data is part of a premarket notification filed by Amend Surgical, Inc. with the FDA for 0.5cc Nanofuse, 1.0cc Nanofuse, 2cc Nanofuse, 5cc Nanofuse, 10cc Nanofuse.
| Device ID | K161996 |
| 510k Number | K161996 |
| Device Name: | 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Amend Surgical, Inc. 13859 Progress Blvd. Suite 300 Alachua, FL 32615 |
| Contact | Robert Lane |
| Correspondent | Lisa C. Simpson Simpson Regulatory Solutions, LLC 4401 NW 18 PL Gainesville, FL 32605 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-19 |
| Decision Date | 2017-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858686006096 | K161996 | 000 |
| 00858686006089 | K161996 | 000 |