FDA.reportPublic FDA data

APOLLO Ankle Fracture Plating System

Primary DI
18435711003597
Brand
APOLLO Ankle Fracture Plating System
Company
Glw, Inc.
Model
F3-1029-020
Catalog number
F3-1029-020
Device description
APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9x20mm
Published
2025-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18435711003597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1843571100359718435711003597

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081102081
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
18435711006550CREED Edge Ortholucent ImplantsR5-1343-065SR5-1343-065S2026-01-28
18435711006574CREED Edge Ortholucent ImplantsR5-1320-070SR5-1320-070S2026-01-28
18435711006604CREED Edge Ortholucent ImplantsR5-3030-100SR5-3030-100S2026-01-28
18435711006642CREED Edge Ortholucent ImplantsR5-1020-055SR5-1020-055S2026-01-28
18435711006666CREED Edge Ortholucent ImplantsR5-2031-070SR5-2031-070S2026-01-28
18435711006710CREED Edge Ortholucent ImplantsR5-2222-075SR5-2222-075S2026-01-28
18435711007762CREED Edge Ortholucent ImplantsF9-1974-034SF9-1974-034S2026-01-28
18435711007779CREED Edge Ortholucent ImplantsF9-1974-036SF9-1974-036S2026-01-28
18435711007786CREED Edge Ortholucent ImplantsF9-1974-038SF9-1974-038S2026-01-28
18435711007793CREED Edge Ortholucent ImplantsF9-1974-040SF9-1974-040S2026-01-28
18435711007809CREED Edge Ortholucent ImplantsF9-1974-042SF9-1974-042S2026-01-28
18435711007816CREED Edge Ortholucent ImplantsF9-1974-044SF9-1974-044S2026-01-28
18435711007823CREED Edge Ortholucent ImplantsF9-1974-046SF9-1974-046S2026-01-28
18435711007830CREED Edge Ortholucent ImplantsF9-1974-048SF9-1974-048S2026-01-28
18435711007847CREED Edge Ortholucent ImplantsF9-1974-050SF9-1974-050S2026-01-28
18435711007854CREED Edge Ortholucent ImplantsF9-1974-055SF9-1974-055S2026-01-28
18435711007861CREED Edge Ortholucent ImplantsF9-1974-060SF9-1974-060S2026-01-28
18435711007878CREED Edge Ortholucent ImplantsF9-1974-065SF9-1974-065S2026-01-28
18435711007885CREED Edge Ortholucent ImplantsF9-1974-070SF9-1974-070S2026-01-28
18435711007892CREED Edge Ortholucent ImplantsF9-1974-075SF9-1974-075S2026-01-28

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