CONTACT® ALP Anterior Lumbar Plate System 25-60-34

GUDID 00846468028497

6.0 x 34 LUMBAR SCREW ASSEMBLY

Pioneer Surgical Technology, Inc.

Spinal fixation plate, non-bioabsorbable
Primary Device ID00846468028497
NIH Device Record Keybb34c6ae-7aa5-4080-a91a-5a99978ddfef
Commercial Distribution StatusIn Commercial Distribution
Brand NameCONTACT® ALP Anterior Lumbar Plate System
Version Model Number25-60-34
Catalog Number25-60-34
Company DUNS793384496
Company NamePioneer Surgical Technology, 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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100846468028497 [Primary]
GS100846468091606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00846468028497]

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[00846468028497]

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[00846468028497]

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[00846468028497]

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[00846468028497]

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[00846468028497]

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[00846468028497]

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[00846468028497]

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[00846468028497]

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[00846468028497]

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[00846468028497]

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[00846468028497]

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[00846468028497]

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[00846468028497]

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[00846468028497]

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[00846468028497]

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[00846468028497]

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[00846468028497]

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[00846468028497]

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[00846468028497]

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[00846468028497]

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[00846468028497]

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[00846468028497]

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[00846468028497]

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[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


[00846468028497]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2015-11-06

On-Brand Devices [CONTACT® ALP Anterior Lumbar Plate System]

00846468029029TEMPORARY HOLDING PIN, THREADED
0084646802897846mm ANTERIOR SACRAL PLATE
0084646802896144mm ANTERIOR SACRAL PLATE
0084646802895442mm ANTERIOR SACRAL PLATE
0084646802894740mm ANTERIOR SACRAL PLATE
0084646802893038mm ANTERIOR SACRAL PLATE
0084646802892336mm ANTERIOR SACRAL PLATE
0084646802891634mm ANTERIOR SACRAL PLATE
00846468028886T-HANDLE, RATCHETING
00846468028879PUSH STYLE TEMPORARY HOLDING PIN
0084646802878746mm ANTERIOR LUMBAR PLATE
0084646802877044mm ANTERIOR LUMBAR PLATE
0084646802876342mm ANTERIOR LUMBAR PLATE
0084646802875640mm ANTERIOR LUMBAR PLATE
0084646802874938mm ANTERIOR LUMBAR PLATE
0084646802873236mm ANTERIOR LUMBAR PLATE
0084646802872534mm ANTERIOR LUMBAR PLATE
00846468028633AUXILIARY PLATE AND SCREW CADDY
008464680286266.5 x 40 RESCUE SCREW ASSEMBLY
008464680286196.5 x 38 RESCUE SCREW ASSEMBLY
008464680286026.5 x 36 RESCUE SCREW ASSEMBLY
008464680285966.5 x 34 RESCUE SCREW ASSEMBLY
008464680285896.5 x 32 RESCUE SCREW ASSEMBLY
008464680285726.5 x 30 RESCUE SCREW ASSEMBLY
008464680285656.5 x 28 RESCUE SCREW ASSEMBLY
008464680285586.5 x 26 RESCUE SCREW ASSEMBLY
008464680285416.5 x 24 RESCUE SCREW ASSEMBLY
008464680285346.5 x 22 RESCUE SCREW ASSEMBLY
008464680285276.0 x 40 LUMBAR SCREW ASSEMBLY
008464680285106.0 x 38 LUMBAR SCREW ASSEMBLY
008464680285036.0 x 36 LUMBAR SCREW ASSEMBLY
008464680284976.0 x 34 LUMBAR SCREW ASSEMBLY
008464680284806.0 x 32 LUMBAR SCREW ASSEMBLY
008464680284736.0 x 30 LUMBAR SCREW ASSEMBLY
008464680284666.0 x 28 LUMBAR SCREW ASSEMBLY
008464680284596.0 x 26 LUMBAR SCREW ASSEMBLY
008464680284426.0 x 24 LUMBAR SCREW ASSEMBLY
008464680284356.0 x 22 LUMBAR SCREW ASSEMBLY

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88319862 not registered Live/Pending
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2019-02-28
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88300050 5901163 Live/Registered
Play'n GO Marks Ltd.
2019-02-13
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87841036 not registered Dead/Abandoned
Orsmond, Albert N.
2018-03-20
CONTACT
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86902846 not registered Dead/Abandoned
Pling, Ali Ibrahim
2016-02-09
CONTACT
CONTACT
86902844 5045013 Live/Registered
Pling, Ali Ibrahim
2016-02-09
CONTACT
CONTACT
86754741 not registered Dead/Abandoned
NLU Products, L.L.C.
2015-09-11
CONTACT
CONTACT
86744575 5223848 Live/Registered
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2015-09-01

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