SPB030

GUDID 10705034245607

SURGICAL POSITIONING BOARD PATIENT PADDING

DEPUY SPINE, LLC

Spinal surgery positioning board
Primary Device ID10705034245607
NIH Device Record Key1af85922-73ff-4f2e-a1d2-0fffbf9cde1a
Commercial Distribution Discontinuation2019-07-31
Commercial Distribution StatusNot in Commercial Distribution
Version Model NumberSPB030
Catalog NumberSPB030
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 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(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110705034245607 [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 Number7
Public Version Date2020-03-23
Device Publish Date2017-06-27

Devices Manufactured by DEPUY SPINE, LLC

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10705034646961 - TRIALTIS Spine System2025-05-29 TRIALTIS Spine System Side by Side Connector, 19mm, Top Notch Open / Closed ø5.5-6mm to 5.5-6mm
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
10705034647005 - TRIALTIS Spine System2025-05-29 TRIALTIS Spine System Side by Side Connector, 21mm, Top Notch Open / Side Loading ø5.5-6mm to 5.5-6.35mm
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