ALPHALOK Plating System TMT-105M

GUDID 00841731131423

ANKLE FX Medial Tibia Plate - Medium

VILEX LLC

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID00841731131423
NIH Device Record Key9335a39c-7ac9-46ae-8f3a-dba76f7f4a48
Commercial Distribution StatusIn Commercial Distribution
Brand NameALPHALOK Plating System
Version Model NumberTMT-105M
Catalog NumberTMT-105M
Company DUNS117502293
Company NameVILEX LLC
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841731131423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


[00841731131423]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-20
Device Publish Date2024-02-12

On-Brand Devices [ALPHALOK Plating System]

00841731128904RECON Fibula Plate, Medium, Right 10 Holes
00841731128898RECON Fibula Plate, Medium, Left 10 Holes
00841731128881RECON Fibula Plate, Small, Right 9 Holes
00841731128874RECON Fibula Plate, Small, Left 9 Holes
00841731128867RECON Fibula Plate, X-Small, Right 8 Holes
00841731128850RECON Fibula Plate, X-Small, Left 8 Holes
00841731128843RECON Straight Fibula Plate - 10 Holes
00841731128836RECON Straight Fibula Plate - 9 Holes
00841731128829RECON Straight Fibula Plate - 8 Holes
00841731128812RECON Straight Fibula Plate - 7 Holes
00841731128805RECON Straight Fibula Plate - 6 Holes
00841731128799RECON Straight Fibula Plate - 5 Holes
00841731128782RECON Tarantula Plate Washer, 15mm
00841731128775RECON Tarantula Plate Washer, 12.5mm
00841731128768RECON Tarantula Plate Washer, 10mm
00841731128751RECON Tarantula Plate Washer, 8mm
00841731128744RECON MTP Plate Revision, 62mm Right
00841731128737RECON MTP Plate Revision, 62mm Left
00841731128720RECON MTP Plate, 48mm Straight Right
00841731128713RECON MTP Plate Large 10D, 53mm Right
00841731128706RECON MTP Plate, 48mm Straight Left
00841731128690RECON MTP Plate Large 10D, 53mm Left
00841731128683RECON MTP Plate Large 5D, 53mm Right
00841731128676RECON MTP Plate Large 5D, 53mm Left
00841731128669RECON MTP Plate Large 0D, 53mm Right
00841731128652RECON MTP Plate Large 0D, 53mm Left
00841731128645RECON MTP Plate Medium 10D, 45mm Right
00841731128638RECON MTP Plate Medium 10D, 45mm Left
00841731128621RECON MTP Plate Medium 5D, 45mm Right
00841731128614RECON MTP Plate Medium 5D, 45mm Left
00841731128607RECON MTP Plate Medium 0D, 45mm Right
00841731128591RECON MTP Plate Medium 0D, 45mm Left
00841731128584RECON MTP Plate Small 10D, 40mm Right
00841731128577RECON MTP Plate Small 10D, 40mm Left
00841731128560RECON MTP Plate Small 5D, 40mm Right
00841731128553RECON MTP Plate Small 5D, 40mm Left
00841731128546RECON MTP Plate Small 0D, 40mm Right
00841731128539RECON MTP Plate Small 0D, 40mm Left
00841731128522RECON Universal Plate, 61mm Right
00841731128515RECON Universal Plate, 61mm Left
00841731128508RECON Universal Plate, 53mm Right
00841731128492RECON Universal Plate, 53mm Left
00841731128485RECON Universal Plate, 39mm Right
00841731128478RECON Universal Plate, 39mm Left
00841731128461RECON Universal Plate, 31mm Right
00841731128454RECON Universal Plate, 31mm Left
00841731128447RECON TN Plate
00841731128430RECON NC Plate, 33mm
00841731128423RECON NC Plate, 28mm
00841731128416RECON Medial Column, 85mm Right

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