Foot and Ankle Plating System 154-350

GUDID 00190837070380

Plate Bender

Life Spine, Inc.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00190837070380
NIH Device Record Key4b8e655d-2901-45e5-ba48-c55bce64e88b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFoot and Ankle Plating System
Version Model Number154-350
Catalog Number154-350
Company DUNS183641617
Company NameLife Spine, 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 Usefalse
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
GS100190837070380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837070380]

Moist Heat or Steam Sterilization


[00190837070380]

Moist Heat or Steam Sterilization


[00190837070380]

Moist Heat or Steam Sterilization


[00190837070380]

Moist Heat or Steam Sterilization


[00190837070380]

Moist Heat or Steam Sterilization


[00190837070380]

Moist Heat or Steam Sterilization


[00190837070380]

Moist Heat or Steam Sterilization


[00190837070380]

Moist Heat or Steam Sterilization


[00190837070380]

Moist Heat or Steam Sterilization


[00190837070380]

Moist Heat or Steam Sterilization


[00190837070380]

Moist Heat or Steam Sterilization


[00190837070380]

Moist Heat or Steam Sterilization


[00190837070380]

Moist Heat or Steam Sterilization


[00190837070380]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-15
Device Publish Date2019-11-07

On-Brand Devices [Foot and Ankle Plating System]

0019083708497410mm Calcaneal Step Plate
001908370849679mm Calcaneal Step Plate
001908370849508mm Calcaneal Step Plate
001908370849437mm Calcaneal Step Plate
001908370849366mm Calcaneal Step Plate
001908370849295mm Calcaneal Step Plate
001908370849124mm Calcaneal Step Plate
0019083708490510mm Calcaneal Step Plate
001908370848999mm Calcaneal Step Plate
001908370848828mm Calcaneal Step Plate
001908370848757mm Calcaneal Step Plate
001908370848686mm Calcaneal Step Plate
001908370848515mm Calcaneal Step Plate
001908370848444mm Calcaneal Step Plate
00190837084837Contoured T Compression Plate, 30mm
00190837084820Contoured T Compression Plate, 20mm
00190837084813Contoured T Compression Plate, 30mm
00190837084806Contoured T Compression Plate, 20mm
00190837084790Contoured T Plate, 30mm
00190837084783Contoured T Plate, 30mm
00190837084776Contoured T Plate, 10mm
00190837084769Contoured T Plate, 30mm
00190837084752Contoured T Plate, 30mm
00190837084745Contoured T Plate, 10mm
00190837084738T Compression Plate, 30mm
00190837084721T Compression Plate, 20mm
00190837084714T Compression Plate, 30mm
00190837084707T Compression Plate, 20mm
00190837084691T Plate, 30mm
00190837084684T Plate, 20mm
00190837084677T Plate, 10mm
00190837084660T Plate, 30mm
00190837084653T Plate, 20mm
00190837084646T Plate, 10mm
00190837084639Straight Compression Plate, 30mm
00190837084622Straight Compression Plate, 20mm
00190837084615Straight Compression Plate, 30mm
00190837084608Straight Compression Plate, 20mm
00190837084592Straight Plate, 30mm
00190837084585Straight Plate, 20mm
00190837084578Straight Plate, 10mm
00190837084561Straight Plate, 30mm
00190837084554Straight Plate, 20mm
00190837084547Straight Plate, 10mm
0019083708453028mm Right Lapidus Compression Plate, 6mm Step
0019083708452328mm Left Lapidus Compression Plate, 6mm Step
0019083708451628mm Right Lapidus Compression Plate, 5mm Step
0019083708450928mm Left Lapidus Compression Plate, 5mm Step
0019083708449328mm Right Lapidus Compression Plate, 4mm Step
0019083708448628mm Left Lapidus Compression Plate, 4mm Step

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