Tailored-H

GUDID 00850018366656

TAILORED-H SCREW - SELF DRILLING - 4.25x14MM

BESPOKE TECHNOLOGIES, LLC

Metallic spinal interbody fusion cage
Primary Device ID00850018366656
NIH Device Record Keyb598637b-7519-4472-ae05-bfb0f91323f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameTailored-H
Version Model NumberBCSD-4214
Company DUNS056684302
Company NameBESPOKE TECHNOLOGIES, LLC
Device Count1
DM Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850018366656 [Primary]

FDA Product Code

OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-31
Device Publish Date2025-03-21

On-Brand Devices [Tailored-H]

00850057425307TAILORED-H 3DTI INTEGRATED IMPLANT - 16x18x10MM - 12°
00850057425291TAILORED-H 3DTI INTEGRATED IMPLANT - 16x18x9MM - 12°
00850057425284TAILORED-H 3DTI INTEGRATED IMPLANT - 16x18x8MM - 12°
00850057425277TAILORED-H 3DTI INTEGRATED IMPLANT - 16x18x7MM - 12°
00850057425260TAILORED-H 3DTI INTEGRATED IMPLANT - 16x18x6MM - 12°
00850057425253TAILORED-H 3DTI INTEGRATED IMPLANT - 16x18x10MM - 7°
00850057425246TAILORED-H 3DTI INTEGRATED IMPLANT - 16x18x9MM - 7°
00850057425239TAILORED-H 3DTI INTEGRATED IMPLANT - 16x18x8MM - 7°
00850057425222TAILORED-H 3DTI INTEGRATED IMPLANT - 16x18x7MM - 7°
00850057425215TAILORED-H 3DTI INTEGRATED IMPLANT - 16x18x6MM - 7°
00850057425208TAILORED-H 3DTI INTEGRATED IMPLANT 15x18x10MM - 12°
00850057425192TAILORED-H 3DTI INTEGRATED IMPLANT 15x18x9MM - 12°
00850057425185TAILORED-H 3DTI INTEGRATED IMPLANT 15x18x8MM - 12°
00850057425178TAILORED-H 3DTI INTEGRATED IMPLANT 15x18x7MM - 12°
00850057425161TAILORED-H 3DTI INTEGRATED IMPLANT 15x18x6MM - 12°
00850057425154TAILORED-H 3DTI INTEGRATED IMPLANT 15x18x10MM - 7°
00850057425147TAILORED-H 3DTI INTEGRATED IMPLANT 15x18x9MM - 7°
00850057425130TAILORED-H 3DTI INTEGRATED IMPLANT 15x18x8MM - 7°
00850057425123TAILORED-H 3DTI INTEGRATED IMPLANT 15x18x7MM - 7°
00850057425116TAILORED-H 3DTI INTEGRATED IMPLANT 15x18x6MM - 7°
00850057425109TAILORED-H 3DTI INTEGRATED IMPLANT 14x16x10MM - 12°
00850057425093TAILORED-H 3DTI INTEGRATED IMPLANT 14x16x9MM - 12°
00850057425086TAILORED-H 3DTI INTEGRATED IMPLANT 14x16x8MM - 12°
00850057425079TAILORED-H 3DTI INTEGRATED IMPLANT 14x16x7MM - 12°
00850057425062TAILORED-H 3DTI INTEGRATED IMPLANT 14x16x6MM - 12°
00850057425055TAILORED-H 3DTI INTEGRATED IMPLANT 14x16x10MM - 7°
00850057425048TAILORED-H 3DTI INTEGRATED IMPLANT 14x16x9MM - 7°
00850057425031TAILORED-H 3DTI INTEGRATED IMPLANT 14x16x8MM - 7°
00850057425024TAILORED-H 3DTI INTEGRATED IMPLANT 14x16x7MM - 7°
00850057425017TAILORED-H 3DTI INTEGRATED IMPLANT 14x16x6MM - 7°
00850018366670TAILORED-H SCREW - SELF DRILLING - 4.25x18MM
00850018366663TAILORED-H SCREW - SELF DRILLING - 4.25x16MM
00850018366656TAILORED-H SCREW - SELF DRILLING - 4.25x14MM
00850018366649TAILORED-H SCREW - SELF DRILLING - 4.25x12MM
00850018366632TAILORED-H SCREW - SELF DRILLING - 4.0x18MM
00850018366625TAILORED-H SCREW - SELF DRILLING - 4.0x16MM
00850018366618TAILORED-H SCREW - SELF DRILLING - 4.0x14MM
00850018366601TAILORED-H SCREW - SELF DRILLING - 4.0x12MM
00850018366595TAILORED-H SCREW - SELF DRILLING - 3.5x18MM
00850018366588TAILORED-H SCREW - SELF DRILLING - 3.5x16MM
00850018366571TAILORED-H SCREW - SELF DRILLING - 3.5x14MM
00850018366564TAILORED-H SCREW - SELF DRILLING - 3.5x12MM
00850018366557TAILORED-H CAGE LOCK ASSY
00850018366915INSERTER & SCREW GUIDE WITH STOP - 12MM
00850018366908INSERTER & SCREW GUIDE WITH STOP - 11MM
00850018366892INSERTER & SCREW GUIDE WITH STOP - 10MM
00850018366885INSERTER & SCREW GUIDE WITH STOP - 9MM
00850018366878INSERTER & SCREW GUIDE WITH STOP - 8MM
00850018366861INSERTER & SCREW GUIDE WITH STOP - 7MM
00850018366854INSERTER & SCREW GUIDE - 12MM
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.