FDA.reportPublic FDA data

ADDITIVE ORTHOPAEDICS, LLC

Matched from indexed company URL: Additive Orthopaedics

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30128278463012827846ADDITIVE ORTHOPAEDICS, LLC1N2020-04-2544 Riverdale Avenue Monmouth Bch NJ US 07750

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
00850005508144Additive Orthopaedic Bone Wedge System - Cotton Bone Segment - 18x14x10x6.5732-882-6633greg@additiveorthopaedics.com
00850005508151Additive Orthopaedic Bone Wedge System - Cotton Bone Segment - 20x14x10x4.5732-882-6633greg@additiveorthopaedics.com
00850005508168Additive Orthopaedic Bone Wedge System - Cotton Bone Segment - 20x14x10x5.5732-882-6633greg@additiveorthopaedics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1977581636953334K170214Additive Orthopaedics Locking Lattice PlateHRS2017-04-13
1977581943273954K163593Additive Orthopaedics Bunion SystemHRS2017-06-20
1977581243266460K160264Additive Orthopaedics Hammertoe Correction SystemHTY2016-06-01
1977581273783858K153207Additive Orthopaedics Bone Wedge SystemHRS2016-09-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS32017-06-20
HTY12016-06-01

PMN#

GUDID#

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