Alphatec Spine Anterior Lumbar Plating System

GUDID 00844856062900

Aspida, 10mm Lumbar Plate

ALPHATEC SPINE, INC.

Orthopaedic fixation plate kit, non-bioabsorbable, sterile
Primary Device ID00844856062900
NIH Device Record Key0aab7cda-5af2-4217-9e10-1929956a133a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlphatec Spine Anterior Lumbar Plating System
Version Model Number51001-10
Company DUNS602465783
Company NameALPHATEC SPINE, INC.
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com

Device Dimensions

Length10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100844856062900 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


[00844856062900]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-08-31

On-Brand Devices [Alphatec Spine Anterior Lumbar Plating System]

00844856063044ALIF Screw, 7.0mm x 35mm
00844856063037ALIF Screw, 7.0mm x 25mm
00844856063020ALIF Screw, 6.0mm x 35mm
00844856063013ALIF Screw, 6.0mm x 25mm
00844856063006Aspida, 18mm Sacral Plate
00844856062993Aspida, 16mm Sacral Plate
00844856062986Aspida, 14mm Sacral Plate
00844856062979Aspida, 12mm Sacral Plate
00844856062962Aspida, 10mm Sacral Plate
00844856062955Aspida, 8mm Sacral Plate
00844856062948Aspida, 18mm Lumbar Plate
00844856062931Aspida, 16mm Lumbar Plate
00844856062924Aspida, 14mm Lumbar Plate
00844856062917Aspida, 12mm Lumbar Plate
00844856062900Aspida, 10mm Lumbar Plate
00844856062894Aspida, 8mm Lumbar Plate
00844856037021ALIF Screw, 7.0mm x 30mm
00844856036956ALIF Screw, 6.0mm x 30mm

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