PolyLock

GUDID 00840124509757

MiniLock HD (2.5mm x 12mm)

FUSION ORTHOPEDICS, LLC

Implantable orthopaedic fixation device connection screw
Primary Device ID00840124509757
NIH Device Record Key870c8cd0-4d60-42d6-abdd-8264d1973897
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolyLock
Version Model NumberML-HD-2512
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
GS100840124509757 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840124509757]

Moist Heat or Steam Sterilization


[00840124509757]

Moist Heat or Steam Sterilization


[00840124509757]

Moist Heat or Steam Sterilization


[00840124509757]

Moist Heat or Steam Sterilization


[00840124509757]

Moist Heat or Steam Sterilization


[00840124509757]

Moist Heat or Steam Sterilization


[00840124509757]

Moist Heat or Steam Sterilization


[00840124509757]

Moist Heat or Steam Sterilization


[00840124509757]

Moist Heat or Steam Sterilization


[00840124509757]

Moist Heat or Steam Sterilization


[00840124509757]

Moist Heat or Steam Sterilization


[00840124509757]

Moist Heat or Steam Sterilization


[00840124509757]

Moist Heat or Steam Sterilization


[00840124509757]

Moist Heat or Steam Sterilization


[00840124509757]

Moist Heat or Steam Sterilization


[00840124509757]

Moist Heat or Steam Sterilization


[00840124509757]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-28
Device Publish Date2024-05-20

On-Brand Devices [PolyLock]

00840124501003Locking Screw SB 2.0mm x 30mm
00840124500990Locking Screw SB 2.0mm x 28mm
00840124500983Locking Screw SB 2.0mm x 26mm
00840124500976Locking Screw SB 2.0mm x 24mm
00840124500242Non-Locking Screw SB 2.0mm x 22mm
00840124500235Non-Locking Screw SB 2.0mm x 20mm
00840124500228Non-Locking Screw SB 2.0mm x 18mm
00840124500211Non-Locking Screw SB 2.0mm x 16mm
00840124500204Non-Locking Screw SB 2.0mm x 14mm
00840124500198Non-Locking Screw SB 2.0mm x 12mm
00840124500181Non-Locking Screw SB 2.0mm x 10mm
00840124500174Non-Locking Screw SB 2.0mm x 8mm
00840124500167Locking Screw SB 2.0mm x 22mm
00840124500150Locking Screw SB 2.0mm x 20mm
00840124500143Locking Screw SB 2.0mm x 18mm
00840124500136Locking Screw SB 2.0mm x 16mm
00840124500129Locking Screw SB 2.0mm x 14mm
00840124500112Locking Screw SB 2.0mm x 12mm
00840124500105Locking Screw SB 2.0mm x 10mm
00840124500099Locking Screw SB 2.0mm x 8mm
00840124500082T-Plate SB 8 Hole
00840124500075T-Plate SB 7 Hole
00840124500068T-Plate SB 6 Hole
00840124500051T-Plate SB 5 Hole
00840124500044Straight Plate SB 8 Hole
00840124500037Straight Plate SB 6 Hole
00840124500020Straight Plate SB 5 Hole
00840124500013Straight Plate SB 4 Hole Static
00840124500006Straight Plate SB 3 Hole
00819034029990Straight Plate SB 2 Hole Static
00819034029983Straight Plate SB 2 Hole
00819034029976Hook Plate SB Right
00819034029969Hook Plate SB Left
00819034029952Jones Fracture Plate SB Right
00819034029945Jones Fracture Plate SB Left
00819034029938Evans Plate SB 12mm
00819034029921Evans Plate SB 10mm
00819034029914Evans Plate SB 8mm
00819034029907Evans Plate SB 6mm
00819034029891Evans Plate SB Neutral
00819034029884Cotton Plate SB 8mm
00819034029877Cotton Plate SB 6mm
00819034029860Cotton Plate SB 4mm
00819034029853Cotton Plate SB Neutral
00840124501102Opening Wedge Plate SB 5mm
00819034027040Opening Wedge Plate SB 4mm
00819034027033Opening Wedge Plate SB 3mm
00840124501041Non-Locking Screw SB 2.0mm x 30mm
00840124501034Non-Locking Screw SB 2.0mm x 28mm
00840124501027Non-Locking Screw SB 2.0mm x 26mm

Trademark Results [PolyLock]

Mark Image

Registration | Serial
Company
Trademark
Application Date
POLYLOCK
POLYLOCK
77847612 3945328 Live/Registered
Pave Tech, Inc.
2009-10-13
POLYLOCK
POLYLOCK
77847612 3945328 Live/Registered
JONES, PAMELA
2009-10-13
POLYLOCK
POLYLOCK
77081186 not registered Dead/Abandoned
Pave Tech, Inc.
2007-01-11
POLYLOCK
POLYLOCK
75664123 not registered Dead/Abandoned
NELSON INDUSTRIES, INC.
1999-03-16
POLYLOCK
POLYLOCK
75650387 2444983 Dead/Cancelled
KREITNGER, BARBARA
1999-02-26
POLYLOCK
POLYLOCK
75531406 2278058 Live/Registered
GUPTA, LAXMI C., MR.
1998-08-05
POLYLOCK
POLYLOCK
74259281 1776529 Dead/Cancelled
SLT North America, Inc.
1992-03-26
POLYLOCK
POLYLOCK
73481171 1345574 Dead/Cancelled
TI FLEXIBLE TUBES LIMITED
1984-05-21
POLYLOCK
POLYLOCK
72450368 1005007 Live/Registered
STUPPY FLORAL, INC.
1973-02-28
POLYLOCK
POLYLOCK
72331112 0906175 Dead/Expired
FELLOWES MANUFACTURING COMPANY
1969-06-27
POLYLOCK
POLYLOCK
72137403 0741722 Dead/Expired
THERACHEMIE CHEMISCH THERAPEUTISCHE GESELLSCHAFT MBH
1962-02-06

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