FDA.reportPublic FDA data

AMEND SURGICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30121617873012161787AMEND SURGICAL, INC.1N2026-01-0114000 NW 126th Ter Alachua FL US 32615

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00858686006034NanoFuse Bioactive Matrix - 1.0 cc - Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dispenser8442813169smathison@amendsurgical.com
00858686006041Bio V BP Bioactive Glass with DBM Putty - Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dispenser8442813169smathison@amendsurgical.com
00858686006058Bio V BP Bioactive Glass with DBM Putty - 2.0 cc - Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dispenser8442813169smathison@amendsurgical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1907231252977011K1619960.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSEMQV2017-02-16
1907231670958641K142104NANOFUSE DBMMQV2015-01-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQV42017-02-16

PMN#

GUDID#