AlignX

GUDID 00842078111239

Partially Threaded Screw - 6.5 x 95 mm

EXTREMITY MEDICAL, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00842078111239
NIH Device Record Key9bfb5199-e4e8-48a4-8c3f-6e1aa952e74d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlignX
Version Model Number136-65195
Company DUNS832720358
Company NameEXTREMITY MEDICAL, 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 Datetrue
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
GS100842078111239 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842078111239]

Moist Heat or Steam Sterilization


[00842078111239]

Moist Heat or Steam Sterilization


[00842078111239]

Moist Heat or Steam Sterilization


[00842078111239]

Moist Heat or Steam Sterilization


[00842078111239]

Moist Heat or Steam Sterilization


[00842078111239]

Moist Heat or Steam Sterilization


[00842078111239]

Moist Heat or Steam Sterilization


[00842078111239]

Moist Heat or Steam Sterilization


[00842078111239]

Moist Heat or Steam Sterilization


[00842078111239]

Moist Heat or Steam Sterilization


[00842078111239]

Moist Heat or Steam Sterilization


[00842078111239]

Moist Heat or Steam Sterilization


[00842078111239]

Moist Heat or Steam Sterilization


[00842078111239]

Moist Heat or Steam Sterilization


[00842078111239]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-04
Device Publish Date2020-10-27

On-Brand Devices [AlignX]

00842078116395Locking Screw - 5.0 x 28mm
00842078116388Locking Screw - 5.0 x 26mm
00842078116371Locking Screw - 5.0 x 24mm
00842078116364Locking Screw - 5.0 x 22mm
00842078116357Non-Locking Screw - 5.0 x 28 mm
00842078116340Non-Locking Screw - 5.0 x 26 mm
00842078116333Non-Locking Screw - 5.0 x 24 mm
00842078116326Non-Locking Screw - 5.0 x 22 mm
00842078116319Locking Screw - 4.0 x 60 mm
00842078116302Locking Screw - 4.0 x 55 mm
00842078116296Locking Screw - 4.0 x 50 mm
00842078116289Non-Locking Screw - 4.0 x 60 mm
00842078116272Non-Locking Screw - 4.0 x 55 mm
00842078116265Non-Locking Screw - 4.0 x 50 mm
00842078116258Lateral Ankle Fusion Plate, TTC, Right
00842078116241Lateral Ankle Fusion Plate, TTC, Left
00842078116234Lateral Ankle Fusion Plate, TT, Right
00842078116227Lateral Ankle Fusion Plate, TT, Left
00842078116210Anterior Ankle Fusion Plate, Standard Narrow, Right
00842078116203Anterior Ankle Fusion Plate, Standard Narrow, Left
00842078110973Locking Screw - 5.0 x 60 mm
00842078110966Locking Screw - 5.0 x 55 mm
00842078110959Locking Screw - 5.0 x 50 mm
00842078110942Locking Screw - 5.0 x 48 mm
00842078110935Locking Screw - 5.0 x 46 mm
00842078110928Locking Screw - 5.0 x 44 mm
00842078110911Locking Screw - 5.0 x 42 mm
00842078110904Locking Screw - 5.0 x 40 mm
00842078110898Locking Screw - 5.0 x 38 mm
00842078110881Locking Screw - 5.0 x 36 mm
00842078110874Locking Screw - 5.0 x 34 mm
00842078110867Locking Screw - 5.0 x 32 mm
00842078110850Locking Screw - 5.0 x 30mm
00842078110843Non-Locking Screw - 5.0 x 60 mm
00842078110836Non-Locking Screw - 5.0 x 55 mm
00842078110829Non-Locking Screw - 5.0 x 50 mm
00842078110812Non-Locking Screw - 5.0 x 48 mm
00842078110805Non-Locking Screw - 5.0 x 46 mm
00842078110799Non-Locking Screw - 5.0 x 44 mm
00842078110782Non-Locking Screw - 5.0 x 42 mm
00842078110775Non-Locking Screw - 5.0 x 40 mm
00842078110768Non-Locking Screw - 5.0 x 38 mm
00842078110751Non-Locking Screw - 5.0 x 36 mm
00842078110744Non-Locking Screw - 5.0 x 34 mm
00842078110737Non-Locking Screw - 5.0 x 32 mm
00842078110720Non-Locking Screw - 5.0 x 30 mm
00842078110713Locking Screw - 4.0 x 45 mm
00842078110706Locking Screw - 4.0 x 40 mm
00842078110690Locking Screw - 4.0 x 38 mm
00842078110683Locking Screw - 4.0 x 36 mm

Trademark Results [AlignX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ALIGNX
ALIGNX
87110109 5150746 Live/Registered
Extremity Medical LLC
2016-07-20
ALIGNX
ALIGNX
87109923 5150743 Live/Registered
Extremity Medical LLC
2016-07-20
ALIGNX
ALIGNX
75565659 2353298 Live/Registered
LIFE TECHNOLOGIES CORPORATION
1998-10-08

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