OZARK Cervical Plate System AA01-44F97V-G1

GUDID 10888857417526

Plate, 4 Level, Size 97 mm

K2M, INC.

Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile
Primary Device ID10888857417526
NIH Device Record Key91737ab6-81dc-49ff-994a-0b59e54483c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameOZARK Cervical Plate System
Version Model NumberAA01-44F97V-G1
Catalog NumberAA01-44F97V-G1
Company DUNS146060863
Company NameK2M, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com

Device Dimensions

Length97 Millimeter
Length97 Millimeter
Length97 Millimeter
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
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Length97 Millimeter
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Length97 Millimeter
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Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
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Length97 Millimeter
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Length97 Millimeter
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Length97 Millimeter
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Length97 Millimeter
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Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter
Device Size Text, specify0
Length97 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110888857417526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-07
Device Publish Date2018-12-12

On-Brand Devices [OZARK Cervical Plate System]

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10888857417762Plate, 5 Level, Size 109 mm
10888857417755Plate, 5 Level, Size 108 mm
10888857417748Plate, 5 Level, Size 107 mm
10888857417731Plate, 5 Level, Size 106 mm
10888857417724Plate, 5 Level, Size 105 mm
10888857417717Plate, 5 Level, Size 104 mm
10888857417700Plate, 5 Level, Size 103 mm
10888857417694Plate, 5 Level, Size 102 mm
10888857417687Plate, 5 Level, Size 101 mm
10888857417670Plate, 5 Level, Size 100 mm
10888857417663Plate, 5 Level, Size 99 mm
10888857417656Plate, 5 Level, Size 98 mm
10888857417649Plate, 5 Level, Size 97 mm
10888857417632Plate, 5 Level, Size 96 mm
10888857417625Plate, 5 Level, Size 95 mm
10888857417618Plate, 5 Level, Size 94 mm
10888857417601Plate, 5 Level, Size 93 mm
10888857417595Plate, 5 Level, Size 92 mm
10888857417588Plate, 5 Level, Size 91 mm
10888857417571Plate, 5 Level, Size 90 mm
10888857417564Plate, 4 Level, Size 101 mm
10888857417557Plate, 4 Level, Size 100 mm
10888857417540Plate, 4 Level, Size 99 mm
10888857417533Plate, 4 Level, Size 98 mm
10888857417526Plate, 4 Level, Size 97 mm
10888857417519Plate, 4 Level, Size 96 mm
10888857417502Plate, 4 Level, Size 95 mm
10888857417496Plate, 4 Level, Size 94 mm
10888857417489Plate, 4 Level, Size 93 mm
10888857417472Plate, 4 Level, Size 92 mm
10888857417465Plate, 4 Level, Size 91 mm
10888857417458Plate, 4 Level, Size 90 mm
10888857417441Plate, 4 Level, Size 89 mm
10888857417434Plate, 4 Level, Size 88 mm
10888857417427Plate, 4 Level, Size 87 mm
10888857417410Plate, 4 Level, Size 86 mm
10888857417403Plate, 4 Level, Size 85 mm
10888857417397Plate, 4 Level, Size 84 mm
10888857417380Plate, 4 Level, Size 83 mm
10888857417373Plate, 4 Level, Size 82 mm
10888857417366Plate, 4 Level, Size 81 mm
10888857417359Plate, 4 Level, Size 80 mm
10888857417342Plate, 4 Level, Size 79 mm
10888857417335Plate, 4 Level, Size 78 mm
10888857417328Plate, 4 Level, Size 77 mm
10888857417311Plate, 4 Level, Size 76 mm
10888857417304Plate, 4 Level, Size 75 mm
10888857417298Plate, 4 Level, Size 74 mm
10888857417281Plate, 4 Level, Size 73 mm

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