Data / Medical devices / United States / Amend Surgical, Inc.
Amend Surgical, Inc.: FDA-registered device maker in Alachua, FL, United States, 2 510(k) clearances
Amend Surgical, Inc. is registered with the FDA (registration 3012161787) in Alachua, FL, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 16, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012161787
- Address
- 14000 NW 126th Ter, Alachua, FL, United States, 32615
- Owner or operator
- Amend Surgical, Inc. (10051002)
- Roles
- Manufacturer
- First device listed
- January 25, 2016
- Registered through
- 2026
- Brand names listed
- APEX BG+, BioV Bioactive Glass with DBM Putty
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | 2 | Manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | MBP | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 16, 2017 | K161996 | 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE | MQV | Substantially Equivalent | Amend Surgical, Inc. | accessdata.fda.gov |
| January 21, 2015 | K142104 | NANOFUSE DBM | MQV | Substantially Equivalent | Nanotherapeutics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Filler, Bone Void, Calcium Compound
- All makers of Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Updated February 16, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.