FDA.reportPublic FDA data

Additive Orthopaedics Locking Lattice System

Primary DI
00850005508441
Brand
Additive Orthopaedics Locking Lattice System
Company
ADDITIVE ORTHOPAEDICS LLC
Model
AOLLP44CS
Device description
Additive Orthopaedics Locking Lattice Connection Screw
Published
2019-08-19
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
K170214000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170214000Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC2017-04-13HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005508441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005508441008500055084418500055084410850005508441

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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Primary DI, Brand, Company table
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