Home GUDID 00850005508052 Additive Orthopaedic Bone Wedge System
Primary DI 00850005508052
Brand Additive Orthopaedic Bone Wedge System
Company ADDITIVE ORTHOPAEDICS LLC
Model AOEW-20-12
Device description Evans Bone Segment - 20x20x12
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 Product Codes# Code, Name table Code Name HRS Plate, Fixation, Bone
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HRS Plate, Fixation, Bone Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850005508052 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850005508052 00850005508052 850005508052 0850005508052
GMDN Terms# Term, Definition table Term Definition Metallic osteotomy fusion cage, sterile A 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)].
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 DI Brand Model Catalog Published 00850005508182 Additive Orthopaedics Hammertoe System AOHT303318i 2019-07-16 00850005508199 Additive Orthopaedics Hammertoe System AOHT3019Ai 2019-07-16 00850005508205 Additive Orthopaedics Hammertoe System AOHT3019i 2019-07-16 00850005508212 Additive Orthopaedics Hammertoe System AOHT3019NCi 2019-07-16 00850005508281 Additive Orthopaedics TMT Wedge AOTMTW-18-5 2019-07-24 00850005508298 Additive Orthopaedics TMT Wedge AOTMTW-18-7 2019-07-24 00850005508304 Additive Orthopaedics MTP Cup and Cone Bone Segment AOMTPW-6-18 2019-07-24 00850005508311 Additive Orthopaedics MTP Cup and Cone Bone Segment AOMTPW-8-18 2019-07-24 00850005508328 Additive Orthopaedics MTP Cup and Cone Bone Segment AOMTPW-10-18 2019-07-24 00850005508335 Additive Orthopaedics MTP Cup and Cone Bone Segment AOMTPW-12-18 2019-07-24 00850005508342 Additive Orthopaedics MTP Cup and Cone Bone Segment AOMTPW-14-18 2019-07-24 00850005508359 Additive Orthopaedics MTP Cup and Cone Bone Segment AOMTPW-6-16 2019-07-24 00850005508366 Additive Orthopaedics MTP Cup and Cone Bone Segment AOMTPW-8-16 2019-07-24 00850005508373 Additive Orthopaedics MTP Cup and Cone Bone Segment AOMTPW-10-16 2019-07-24 00850005508380 Additive Orthopaedics MTP Cup and Cone Bone Segment AOMTPW-12-16 2019-07-24 00850005508397 Additive Orthopaedics MTP Cup and Cone Bone Segment AOMTPW-14-16 2019-07-24 00850005508403 Additive Orthopaedics MTP Revision Plate AOMTPRP-55-9 2019-07-24 00850005508410 Additive Orthopaedics Locking Lattice System AOLLPS2H-NL 2019-08-19 00850005508427 Additive Orthopaedics Locking Lattice System AOLLPS3H-NL 2019-08-19 00850005508434 Additive Orthopaedics Locking Lattice System AOLLPS4H-NL 2019-08-19
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