FDA.reportPublic FDA data

Additive Orthopaedic Bone Wedge System

Primary DI
00850005508137
Brand
Additive Orthopaedic Bone Wedge System
Company
ADDITIVE ORTHOPAEDICS LLC
Model
AOCW-18-5.5
Device description
Cotton Bone Segment - 18x14x10x5.5
Published
2019-03-05
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
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153207000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153207000Additive Orthopaedics Bone Wedge SystemAdditive Orthopaedics, LLC2016-09-07HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005508137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005508137008500055081378500055081370850005508137

GMDN Terms#

Term, Definition table
TermDefinition
Metallic osteotomy fusion cage, sterileA sterile device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia), or other bone (e.g., tarsal, carpel), following osteotomy to help facilitate bone fusion and alignment; it may be used with a plating fixation system and may be used in association with a bone substitute/graft. The device is typically designed as a small, wedge-shaped cylinder (or other geometric form) and is made of metal [e.g., titanium (Ti)].

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
00850005508212Additive Orthopaedics Hammertoe SystemAOHT3019NCi2019-07-16
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

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