Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012161787

FEI Number

3012161787

Entity Name

AMEND SURGICAL, INC.

City/State/Country

Alachua, FL, US

Establishment Address

14000 NW 126th Ter, Alachua, FL 32615, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Amend Surgical, Inc. (Owner Number: 10051002)

Owner / Operator Contact Address

14000 NW 126th Ter, Alachua, FL 32615, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161996

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2019-06-20

Official Correspondent

Robby Lane

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Amend Surgical, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15
K023703	Berkeley Advanced Biomaterials, Inc.	BI-OSTETIC	2003-01-30
K173933	Xenco Medical, LLC	Sorrento Bioglass Bone Graft Substitute	2018-09-13

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3043620406	REVOGEN BIOLOGICS	San Antonio, TX, US
3016050940	Olive Branch Distribution Center	Olive Branch, MS, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012161787. Last updated year: 2026. Please use registration number 3012161787 when referencing this establishment in official correspondence.