Contact ALP

GUDID 00840311232857

Inserter

Surgalign Spine Technologies, Inc.

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable
Primary Device ID00840311232857
NIH Device Record Key75b69c75-7f75-4e97-9033-a0bf855789db
Commercial Distribution StatusIn Commercial Distribution
Brand NameContact ALP
Version Model Number25-INSERTER
Company DUNS014520584
Company NameSurgalign Spine Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840311232857 [Primary]

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840311232857]

Moist Heat or Steam Sterilization

[00840311232857]

Moist Heat or Steam Sterilization

[00840311232857]

Moist Heat or Steam Sterilization

[00840311232857]

Moist Heat or Steam Sterilization

[00840311232857]

Moist Heat or Steam Sterilization

[00840311232857]

Moist Heat or Steam Sterilization

[00840311232857]

Moist Heat or Steam Sterilization

[00840311232857]

Moist Heat or Steam Sterilization

[00840311232857]

Moist Heat or Steam Sterilization

[00840311232857]

Moist Heat or Steam Sterilization

[00840311232857]

Moist Heat or Steam Sterilization

[00840311232857]

Moist Heat or Steam Sterilization

[00840311232857]

Moist Heat or Steam Sterilization

[00840311232857]

Moist Heat or Steam Sterilization

[00840311232857]

Moist Heat or Steam Sterilization

[00840311232857]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-21
Device Publish Date2023-06-13

On-Brand Devices [Contact ALP]

0084031123315154mm Anterior Sacral Plate
0084031123314452mm Anterior Sacral Plate
0084031123313750mm Anterior Sacral Plate
0084031123312048mm Anterior Sacral Plate
0084031123311346mm Anterior Sacral Plate
0084031123310644mm Anterior Sacral Plate
0084031123309042mm Anterior Sacral Plate
0084031123308340mm Anterior Sacral Plate
0084031123307638mm Anterior Sacral Plate
0084031123306936mm Anterior Sacral Plate
0084031123305234mm Anterior Sacral Plate
0084031123297054mm Anterior Lumbar Plate
0084031123296352mm Anterior Lumbar Plate
0084031123295650mm Anterior Lumbar Plate
0084031123294948mm Anterior Lumbar Plate
0084031123293246mm Anterior Lumbar Plate
0084031123292544mm Anterior Lumbar Plate
0084031123291842mm Anterior Lumbar Plate
0084031123290140mm Anterior Lumbar Plate
0084031123289538mm Anterior Lumbar Plate
0084031123288836mm Anterior Lumbar Plate
0084031123287134mm Anterior Lumbar Plate
008403112327726.5 X 40 Rescue Screw Assembly
008403112327656.5 X 38 Rescue Screw Assembly
008403112327586.5 X 36 Rescue Screw Assembly
008403112327416.5 X 34 Rescue Screw Assembly
008403112327346.5 X 32 Rescue Screw Assembly
008403112327276.5 X 30 Rescue Screw Assembly
008403112327106.5 X 28 Rescue Screw Assembly
008403112327036.5 X 26 Rescue Screw Assembly
008403112326976.5 X 24 Rescue Screw Assembly
008403112326806.5 X 22 Rescue Screw Assembly
008403112326736.0 X 40 Lumbar Screw Assembly
008403112326666.0 X 38 Lumbar Screw Assembly
008403112326596.0 X 36 Lumbar Screw Assembly
008403112326426.0 X 34 Lumbar Screw Assembly
008403112326356.0 X 32 Lumbar Screw Assembly
008403112326286.0 X 30 Lumbar Screw Assembly
008403112326116.0 X 28 Lumbar Screw Assembly
008403112326046.0 X 26 Lumbar Screw Assembly
008403112325986.0 X 24 Lumbar Screw Assembly
008403112325816.0 X 22 Lumbar Screw Assembly
00840311233243Contact ALP, Threaded Screw Inserter
00840311233182Torque Limiting Handle, 1/4" Hex Drive
00840311233175Tightener
00840311233021RATCHETING T-HANDLE, 1/4" SQUARE DRIVE
00840311232987Palm Handle, 1/4" Square Drive
00840311232864Locker
00840311232857Inserter
00840311232840Holder
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