Monaco Uni-Planar

GUDID 00843210169439

Thoracic Lamina Hook, Offset, Large-Left

Altus Spine, LLC

Bone-screw internal spinal fixation system hook Bone-screw internal spinal fixation system hook Bone-screw internal spinal fixation system hook Bone-screw internal spinal fixation system hook Bone-screw internal spinal fixation system hook Bone-screw internal spinal fixation system hook Bone-screw internal spinal fixation system hook Bone-screw internal spinal fixation system hook Bone-screw internal spinal fixation system hook Bone-screw internal spinal fixation system hook Bone-screw internal spinal fixation system hook Bone-screw internal spinal fixation system hook Bone-screw internal spinal fixation system hook Bone-screw internal spinal fixation system hook Bone-screw internal spinal fixation system hook Bone-screw internal spinal fixation system hook Bone-screw internal spinal fixation system hook
Primary Device ID00843210169439
NIH Device Record Key77925100-9ad8-42f4-8c7f-8fb41a5d0d10
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonaco Uni-Planar
Version Model Number831-1600
Company DUNS078331322
Company NameAltus Spine, 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

Customer Support Contacts

Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100843210169439 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00843210169439]

Moist Heat or Steam Sterilization

[00843210169439]

Moist Heat or Steam Sterilization

[00843210169439]

Moist Heat or Steam Sterilization

[00843210169439]

Moist Heat or Steam Sterilization

[00843210169439]

Moist Heat or Steam Sterilization

[00843210169439]

Moist Heat or Steam Sterilization

[00843210169439]

Moist Heat or Steam Sterilization

[00843210169439]

Moist Heat or Steam Sterilization

[00843210169439]

Moist Heat or Steam Sterilization

[00843210169439]

Moist Heat or Steam Sterilization

[00843210169439]

Moist Heat or Steam Sterilization

[00843210169439]

Moist Heat or Steam Sterilization

[00843210169439]

Moist Heat or Steam Sterilization

[00843210169439]

Moist Heat or Steam Sterilization

[00843210169439]

Moist Heat or Steam Sterilization

[00843210169439]

Moist Heat or Steam Sterilization

[00843210169439]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-01
Device Publish Date2023-12-22

On-Brand Devices [Monaco Uni-Planar]

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00843210170039Pedicle Screw, 9.5mm x 110mm
00843210170022Pedicle Screw, 9.5mm x 100mm
00843210170015Pedicle Screw, 9.5mm x 90mm
00843210170008Pedicle Screw, 9.5mm x 80mm
00843210169996Pedicle Screw, 9.5mm x 70mm
00843210169989Pedicle Screw, 9.5mm x 60mm
00843210169972Pedicle Screw, 9.5mm x 55mm
00843210169965Pedicle Screw, 9.5mm x 50mm
00843210151014Pedicle Screw, 5.5mm x 60mm
00843210151007Pedicle Screw, 5.5mm x 55mm
00843210150994Pedicle Screw, 5.5mm x 50mm
00843210150987Pedicle Screw, 5.5mm x 45mm
00843210150970Pedicle Screw, 5.5mm x 40mm
00843210150963Pedicle Screw, 5.5mm x 35mm
00843210150956Pedicle Screw, 5.5mm x 30mm
00843210150949Pedicle Screw, 5.5mm x 25mm
00843210150932Pedicle Screw, 4.5mm x 60mm
00843210150925Pedicle Screw, 4.5mm x 55mm
00843210150918Pedicle Screw, 4.5mm x 50mm
00843210150901Pedicle Screw, 4.5mm x 45mm
00843210150895Pedicle Screw, 4.5mm x 40mm
00843210150888Pedicle Screw, 4.5mm x 35mm
00843210150871Pedicle Screw, 4.5mm x 30mm
00843210150864Pedicle Screw, 4.5mm x 25mm
00843210169811Pedicle Screw, 8.5mm x 45mm
00843210169804Pedicle Screw, 85mm x 40mm
00843210169798Pedicle Screw, 85mm x 35mm
00843210169781Pedicle Screw, 8.5mm x 30mm
00843210169774Pedicle Screw, 8.5mm x 25mm
00843210169767Pedicle Screw, 7.5mm x 120mm
00843210169750Pedicle Screw, 7.5mm x 110mm
00843210169743Pedicle Screw, 7.5mm x 100mm
00843210169736Pedicle Screw, 7.5mm x 90mm
00843210169729Pedicle Screw, 7.5mm x 80mm
00843210169712Pedicle Screw, 7.5mm x 70mm
00843210169705Pedicle Screw, 7.5mm x 60mm
00843210169699Pedicle Screw, 7.5mm x 55mm
00843210169682Pedicle Screw,7.5mm x 50mm
00843210169675Pedicle Screw, 7.5mm x 45mm
00843210169668Pedicle Screw, 7.5mm x 40mm
00843210169651Pedicle Screw, 7.5mm x 35mm
00843210169644Pedicle Screw, 7.5mm x 30mm
00843210169637Pedicle Screw, 7.5mm x 25mm
00843210151151Pedicle Screw,6.5mm x 120mm
00843210151144Pedicle Screw, 6.5mm x 110mm
00843210151137Pedicle Screw, 6.5mm x 100mm
00843210151120Pedicle Screw, 6.5mm x 90mm
00843210151113Pedicle Screw, 6.5mm x 80mm
00843210151106Pedicle Screw, 6.5mm x 70mm
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