FDA.reportPublic FDA data

Additive Orthopaedics Hammertoe System

Primary DI
00850005508212
Brand
Additive Orthopaedics Hammertoe System
Company
ADDITIVE ORTHOPAEDICS LLC
Model
AOHT3019NCi
Device description
Additive Orthopaedics Hammertoe System - Includes 3.0/3.9 Non-Cannulated Implant - ST
Published
2019-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTYPin, Fixation, Smooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160264000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160264000Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC2016-06-01HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005508212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005508212008500055082128500055082120850005508212

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
732-882-6633greg@additiveorthopaedics.com

Regulatory Flags#

DUNS number
085503457
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005508182Additive Orthopaedics Hammertoe SystemAOHT303318i2019-07-16
00850005508199Additive Orthopaedics Hammertoe SystemAOHT3019Ai2019-07-16
00850005508205Additive Orthopaedics Hammertoe SystemAOHT3019i2019-07-16
00850005508281Additive Orthopaedics TMT WedgeAOTMTW-18-52019-07-24
00850005508298Additive Orthopaedics TMT WedgeAOTMTW-18-72019-07-24
00850005508304Additive Orthopaedics MTP Cup and Cone Bone SegmentAOMTPW-6-182019-07-24
00850005508311Additive Orthopaedics MTP Cup and Cone Bone SegmentAOMTPW-8-182019-07-24
00850005508328Additive Orthopaedics MTP Cup and Cone Bone SegmentAOMTPW-10-182019-07-24
00850005508335Additive Orthopaedics MTP Cup and Cone Bone SegmentAOMTPW-12-182019-07-24
00850005508342Additive Orthopaedics MTP Cup and Cone Bone SegmentAOMTPW-14-182019-07-24
00850005508359Additive Orthopaedics MTP Cup and Cone Bone SegmentAOMTPW-6-162019-07-24
00850005508366Additive Orthopaedics MTP Cup and Cone Bone SegmentAOMTPW-8-162019-07-24
00850005508373Additive Orthopaedics MTP Cup and Cone Bone SegmentAOMTPW-10-162019-07-24
00850005508380Additive Orthopaedics MTP Cup and Cone Bone SegmentAOMTPW-12-162019-07-24
00850005508397Additive Orthopaedics MTP Cup and Cone Bone SegmentAOMTPW-14-162019-07-24
00850005508403Additive Orthopaedics MTP Revision PlateAOMTPRP-55-92019-07-24
00850005508410Additive Orthopaedics Locking Lattice SystemAOLLPS2H-NL2019-08-19
00850005508427Additive Orthopaedics Locking Lattice SystemAOLLPS3H-NL2019-08-19
00850005508434Additive Orthopaedics Locking Lattice SystemAOLLPS4H-NL2019-08-19
00850005508441Additive Orthopaedics Locking Lattice SystemAOLLP44CS2019-08-19

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