APOLLO Ankle Fracture Plating System F3-1037-038

GUDID 18435711004679

APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x38mm

Glw, Inc.

Orthopaedic bone screw (non-sliding)
Primary Device ID18435711004679
NIH Device Record Key471b8192-854b-4ea4-ac81-87fc73609c26
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPOLLO Ankle Fracture Plating System
Version Model NumberF3-1037-038
Catalog NumberF3-1037-038
Company DUNS081102081
Company NameGlw, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS118435711004679 [Primary]

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-07
Device Publish Date2025-01-30

On-Brand Devices [APOLLO Ankle Fracture Plating System]

18435711005218T15 self-retaining driver
18435711004938Apollo Ankle Fracture Plates / Apollo Lag Drill Kit Ø4.5 / for Screw 4.3
18435711004921Apollo Ankle Fracture Plates / Apollo Lag Drill Kit Ø4.0 / for Screw 3.7
18435711004914Apollo Ankle Fracture Plates / Apollo Lag Drill Kit Ø3.35 / for Screw 2.9
18435711004907Apollo Ankle Fracture Plates / Apollo K-wire Kit Ø1.6 / Single Use Kit
18435711004891Apollo Ankle Fracture Plates / Apollo Single Use Kit / Drills & Olive Wires
18435711004785APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x67.5mm
18435711004778APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x62.5mm
18435711004761APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x57.5mm
18435711004754APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x52.5mm
18435711004747APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x47.5mm
18435711004730APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x42.5mm
18435711004723APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x37.5mm
18435711004716APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x32.5mm
18435711004709APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x30mm
18435711004693APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x27.5mm
18435711004686APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x25mm
18435711004679APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x38mm
18435711004662APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7x38mm
18435711004655APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9x08mm
18435711004648APOLLO Ankle Fracture Plates / 2.9mm / Non-Locking Screw / 2.9x08mm
18435711004631Apollo Ankle Fracture Plates / Lag Kit / 4.3 screw
18435711004624Apollo Ankle Fracture Plates / Lag Kit / 3.7 screw
18435711004600APOLLO Ankle Fracture Plates / Washer / 7.5mm OD
18435711004433Apollo Ankle Fracture Plates / Sterile Trial Package /
18435711004402Apollo Ankle Fracture Plates / Single Use Hook Kit /
18435711004327Apollo Ankle Fracture Plates / Lag Kit / 2.9 screw
18435711004228APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x70mm
18435711004211APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x65mm
18435711004204APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x60mm
18435711004198APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x55mm
18435711004181APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x50mm
18435711004174APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x45mm
18435711004167APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x40mm
18435711004150APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x35mm
18435711004143APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x60mm
18435711004136APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x57.5mm
18435711004129APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x55mm
18435711004112APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x52.5mm
18435711004105APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x50mm
18435711004099APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x47.5mm
18435711004082APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x45mm
18435711004075APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x42.5mm
18435711004068APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x40mm
18435711004051APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x36mm
18435711004044APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x34mm
18435711004037APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x32mm
18435711004020APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x30mm
18435711004013APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x28mm
18435711004006APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x26mm

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