PolyLock Small Bone SB-LA-3000

GUDID 00840124506312

Lapidus U Plate Left

FUSION ORTHOPEDICS, LLC

Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID00840124506312
NIH Device Record Keyc41f7b65-a3c4-4a47-b96d-e8f3bfdf7051
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolyLock Small Bone
Version Model NumberSB-LA-3000
Catalog NumberSB-LA-3000
Company DUNS080307067
Company NameFUSION ORTHOPEDICS, LLC
Device Count1
DM Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840124506312 [Primary]

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840124506312]

Moist Heat or Steam Sterilization


[00840124506312]

Moist Heat or Steam Sterilization


[00840124506312]

Moist Heat or Steam Sterilization


[00840124506312]

Moist Heat or Steam Sterilization


[00840124506312]

Moist Heat or Steam Sterilization


[00840124506312]

Moist Heat or Steam Sterilization


[00840124506312]

Moist Heat or Steam Sterilization


[00840124506312]

Moist Heat or Steam Sterilization


[00840124506312]

Moist Heat or Steam Sterilization


[00840124506312]

Moist Heat or Steam Sterilization


[00840124506312]

Moist Heat or Steam Sterilization


[00840124506312]

Moist Heat or Steam Sterilization


[00840124506312]

Moist Heat or Steam Sterilization


[00840124506312]

Moist Heat or Steam Sterilization


[00840124506312]

Moist Heat or Steam Sterilization


[00840124506312]

Moist Heat or Steam Sterilization


[00840124506312]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-28
Device Publish Date2021-12-20

On-Brand Devices [PolyLock Small Bone]

00840124506329Lapidus U Plate Right
00840124506312Lapidus U Plate Left
00840124506718Non-Locking Screw SB 2.7mm x 32mm
00840124507159Olive Wire 2.0mm Threaded
00840124513730TailorsLock Plate (New)
00840124513723TailorsLock Tray
00840124507487MiniLock K-Wire Lag Guide

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