SPB001

GUDID 10705034341996

SURGICAL POSITIONING BOARD ASSEMBLY

DEPUY SPINE, LLC

Spinal surgery positioning board
Primary Device ID10705034341996
NIH Device Record Keyf94358fa-d244-4a32-98f7-8a339dee737e
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSPB001
Catalog NumberSPB001
Company DUNS107105876
Company NameDEPUY SPINE, LLC
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 Batchfalse
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(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110705034341996 [Primary]

FDA Product Code

JEBTABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-23
Device Publish Date2016-12-31

Devices Manufactured by DEPUY SPINE, LLC

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10705034646978 - TRIALTIS Spine System2025-05-29 TRIALTIS Spine System Side by Side Connector, 19mm, Top Notch Open / Open ø5.5-6mm to 5.5-6mm
10705034646985 - TRIALTIS Spine System2025-05-29 TRIALTIS Spine System Side by Side Connector, 17mm, Top Notch Open / Side Loading ø5.5-6mm to 5.5-6.35mm
10705034646992 - TRIALTIS Spine System2025-05-29 TRIALTIS Spine System Side by Side Connector, 17mm, Top Notch Open / Closed ø5.5-6mm to 5.5-6mm
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