FDA.reportPublic FDA data

Paragon 28 Bone Wedge System

Primary DI
00889795120076
Brand
Paragon 28 Bone Wedge System
Company
Paragon 28, Inc.
Model
AOCW-16-8
Catalog number
AOCW-16-8
Device description
AO COTTON BONE SEG 16 X 8
Published
2022-10-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795120076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795120076008897951200768897951200760889795120076

GMDN Terms#

Term, Definition table
TermDefinition
Metallic osteotomy fusion cage, non-customizedA non-customized 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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
042961576
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889795135278Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-1P50-900-AFSL-12026-09-24
00889795135285Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-2P50-900-AFSL-22026-09-24
00889795135292Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-3P50-900-AFSL-32026-09-24
00889795135308Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-4P50-900-AFSL-42026-09-24
00889795135315Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-5P50-900-AFSL-52026-09-24
00889795135322Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-6P50-900-AFSL-62026-09-24
00889795135339Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-7P50-900-AFSL-72026-09-24
00889795120199Paragon 28 Bone Wedge SystemAOCWO-16-5AOCWO-16-52023-06-26
00889795120632Paragon 28 Bone Wedge SystemAOLEW-22-12AOLEW-22-122023-04-04
00889795118523Paragon 28 Bone Wedge SystemAOCW-TRL-16-4.5AOCW-TRL-16-4.52022-10-14
00889795118530Paragon 28 Bone Wedge SystemAOCW-TRL-16-5.5AOCW-TRL-16-5.52022-10-14
00889795118547Paragon 28 Bone Wedge SystemAOCW-TRL-16-6.5AOCW-TRL-16-6.52022-10-14
00889795118554Paragon 28 Bone Wedge SystemAOCW-TRL-18-4.5AOCW-TRL-18-4.52022-10-14
00889795118561Paragon 28 Bone Wedge SystemAOCW-TRL-18-5.5AOCW-TRL-18-5.52022-10-14
00889795118578Paragon 28 Bone Wedge SystemAOCW-TRL-18-6.5AOCW-TRL-18-6.52022-10-14
00889795118585Paragon 28 Bone Wedge SystemAOCW-TRL-20-4.5AOCW-TRL-20-4.52022-10-14
00889795118592Paragon 28 Bone Wedge SystemAOCW-TRL-20-5.5AOCW-TRL-20-5.52022-10-14
00889795118608Paragon 28 Bone Wedge SystemAOCW-TRL-20-6.5AOCW-TRL-20-6.52022-10-14
00889795118615Paragon 28 Bone Wedge SystemAOEW-18-8 TRLAOEW-18-8 TRL2022-10-14
00889795118622Paragon 28 Bone Wedge SystemAOEW-18-10 TRLAOEW-18-10 TRL2022-10-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889095401820ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
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00889095411287ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
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00889095411324ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095611274ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
10886982350732VOLTSynthes GmbHHRS2026-09-25
10886982350749VOLTSynthes GmbHHRS2026-09-25
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10886982350831VOLTSynthes GmbHHRS2026-09-25
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10886982350855VOLTSynthes GmbHHRS2026-09-25
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