PolyLock Small Bone TN-TR-0063

GUDID 00840124513723

TailorsLock Tray

FUSION ORTHOPEDICS, LLC

Device sterilization/disinfection container, reusable
Primary Device ID00840124513723
NIH Device Record Keyfbc8a81d-37ea-4c8e-85bb-41fdf578978a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolyLock Small Bone
Version Model NumberTN-TR-0063
Catalog NumberTN-TR-0063
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 Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840124513723 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840124513723]

Moist Heat or Steam Sterilization


[00840124513723]

Moist Heat or Steam Sterilization


[00840124513723]

Moist Heat or Steam Sterilization


[00840124513723]

Moist Heat or Steam Sterilization


[00840124513723]

Moist Heat or Steam Sterilization


[00840124513723]

Moist Heat or Steam Sterilization


[00840124513723]

Moist Heat or Steam Sterilization


[00840124513723]

Moist Heat or Steam Sterilization


[00840124513723]

Moist Heat or Steam Sterilization


[00840124513723]

Moist Heat or Steam Sterilization


[00840124513723]

Moist Heat or Steam Sterilization


[00840124513723]

Moist Heat or Steam Sterilization


[00840124513723]

Moist Heat or Steam Sterilization


[00840124513723]

Moist Heat or Steam Sterilization


[00840124513723]

Moist Heat or Steam Sterilization


[00840124513723]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-09
Device Publish Date2024-08-01

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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