AMP

GUDID 00190376151274

LLIF AMP, ONE SCREW PLATE, 16

ALPHATEC SPINE, INC.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device ID00190376151274
NIH Device Record Key6e66b4e4-d178-4695-845d-3cc9e32e1b9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMP
Version Model Number116-01-16
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

Device Dimensions

Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100190376151274 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral fusion device with integrated fixation, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190376151274]

Moist Heat or Steam Sterilization


[00190376151274]

Moist Heat or Steam Sterilization


[00190376151274]

Moist Heat or Steam Sterilization


[00190376151274]

Moist Heat or Steam Sterilization


[00190376151274]

Moist Heat or Steam Sterilization


[00190376151274]

Moist Heat or Steam Sterilization


[00190376151274]

Moist Heat or Steam Sterilization


[00190376151274]

Moist Heat or Steam Sterilization


[00190376151274]

Moist Heat or Steam Sterilization


[00190376151274]

Moist Heat or Steam Sterilization


[00190376151274]

Moist Heat or Steam Sterilization


[00190376151274]

Moist Heat or Steam Sterilization


[00190376151274]

Moist Heat or Steam Sterilization


[00190376151274]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-20
Device Publish Date2020-01-10

On-Brand Devices [AMP]

00190376206288LIF AMP, TWO SCREW PLATE, 05
00190376206271LIF AMP, TWO SCREW PLATE, 04
00190376206264LIF AMP, ONE SCREW PLATE, 16
00190376206257LIF AMP, ONE SCREW PLATE, 15
00190376206240LIF AMP, ONE SCREW PLATE, 14
00190376206233LIF AMP, ONE SCREW PLATE, 13
00190376206226LIF AMP, ONE SCREW PLATE, 12
00190376206219LIF AMP, ONE SCREW PLATE, 11
00190376206202LIF AMP, ONE SCREW PLATE, 10
00190376206196LIF AMP, ONE SCREW PLATE, 09
00190376206189LIF AMP, ONE SCREW PLATE, 08
00190376206172LIF AMP, ONE SCREW PLATE, 07
00190376206165LIF AMP, ONE SCREW PLATE, 06
00190376206158LIF AMP, ONE SCREW PLATE, 05
00190376206141LIF AMP, ONE SCREW PLATE, 04
00190376206134LIF AMP, Ø6.5mm x 65mm BONE SCREW
00190376206127LIF AMP, Ø6.5mm x 60mm BONE SCREW
00190376206110LIF AMP, Ø6.5mm x 55mm BONE SCREW
00190376206103LIF AMP, Ø6.5mm x 50mm BONE SCREW
00190376206097LIF AMP, Ø6.5mm x 45mm BONE SCREW
00190376206080LIF AMP, Ø6.5mm x 40mm BONE SCREW
00190376206073LIF AMP, Ø6.5mm x 35mm BONE SCREW
00190376206066LIF AMP, Ø6.5mm x 30mm BONE SCREW
00190376206059LIF AMP, Ø6.5mm x 25mm BONE SCREW
00190376206042LIF AMP, Ø6.0mm x 65mm BONE SCREW
00190376206035LIF AMP, Ø6mm x 60mm BONE SCREW
00190376206028LIF AMP, Ø6mm x 55mm BONE SCREW
00190376206011LIF AMP, Ø6mm x 50mm BONE SCREW
00190376206004LIF AMP, Ø6mm x 45mm BONE SCREW
00190376205991LIF AMP, Ø6mm x 40mm BONE SCREW
00190376205984LIF AMP, Ø6mm x 35mm BONE SCREW
00190376205977LIF AMP, Ø6mm x 30mm BONE SCREW
00190376205960LIF AMP, Ø6mm x 25mm BONE SCREW
00190376205953LIF AMP, Ø5.5mm x 65mm BONE SCREW
00190376205946LIF AMP, Ø5.5mm x 60mm BONE SCREW
00190376205939LIF AMP, Ø5.5mm x 55mm BONE SCREW
00190376205922LIF AMP, Ø5.5mm x 50mm BONE SCREW
00190376205915LIF AMP, Ø5.5mm x 45mm BONE SCREW
00190376205908LIF AMP, Ø5.5mm x 40mm BONE SCREW
00190376205892LIF AMP, Ø5.5mm x 35mm BONE SCREW
00190376205885LIF AMP, Ø5.5mm x 30mm BONE SCREW
00190376205878LIF AMP, Ø5.5mm x 25mm BONE SCREW
00190376205861LIF AMP, CENTER SCREW, 20mm
00190376205854LIF AMP, CENTER SCREW, 17.5mm
00190376205847LIF AMP, CENTER SCREW, 15mm
00190376205830LIF AMP, CENTER SCREW, 12.5mm
00190376205823LIF AMP, CENTER SCREW, 10mm
00190376205816LIF AMP, TWO SCREW PLATE, 16
00190376205809LIF AMP, TWO SCREW PLATE, 15
00190376205793LIF AMP, TWO SCREW PLATE, 14

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