Gallery Laminoplasty Fixation System 14-523095

GUDID 03662663146432

GALLERY 2.4X5MM S-D SCREW

Highridge Medical, LLC

Spinal bone screw, non-bioabsorbable
Primary Device ID03662663146432
NIH Device Record Key57eb7010-6819-4fc1-8fbe-682d619b22d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameGallery Laminoplasty Fixation System
Version Model Number14-523095
Catalog Number14-523095
Company DUNS119260394
Company NameHighridge Medical, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com
Phone+1(800)447-3625
Emailusbrocustomerservice@highridgemedical.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS103662663146432 [Primary]

FDA Product Code

NQWORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03662663146432]

Moist Heat or Steam Sterilization

[03662663146432]

Moist Heat or Steam Sterilization

[03662663146432]

Moist Heat or Steam Sterilization

[03662663146432]

Moist Heat or Steam Sterilization

[03662663146432]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-11-24
Device Publish Date2025-11-15

On-Brand Devices [Gallery Laminoplasty Fixation System]

03662663146517GALLERY 2.8X11MM S-D SCREW
03662663146500GALLERY 2.8X9MM S-D SCREW
03662663146494GALLERY 2.8X7MM S-D SCREW
03662663146487GALLERY 2.8X5MM S-D SCREW
03662663146470GALLERY 2.4X13MM S-D SCREW
03662663146463GALLERY 2.4X11MM S-D SCREW
03662663146456GALLERY 2.4X9MM S-D SCREW
03662663146449GALLERY 2.4X7MM S-D SCREW
03662663146432GALLERY 2.4X5MM S-D SCREW
03662663146425GALLERY 2.0X13MM S-D SCREW
03662663146418GALLERY 2.0X11MM S-D SCREW
03662663146401GALLERY 2.0X9MM S-D SCREW
03662663146395GALLERY 2.0X7MM S-D SCREW
03662663146388GALLERY 2.0X5MM S-D SCREW
03662663146371GALLERY 2.8X13MM S-T SCREW
03662663146364GALLERY 2.8X11MM S-T SCREW
03662663146357GALLERY 2.8X9MM S-T SCREW
03662663146340GALLERY 2.8X7MM S-T SCREW
03662663146333GALLERY 2.8X5MM S-T SCREW
03662663146326GALLERY 2.4X13MM S-T SCREW
03662663146319GALLERY 2.4X11MM S-T SCREW
03662663146302GALLERY 2.4X9MM S-T SCREW
03662663146296GALLERY 2.4X7MM S-T SCREW
03662663146289GALLERY 2.4X5MM S-T SCREW
03662663146272GALLERY 2.0X13MM S-T SCREW
03662663146265GALLERY 2.0X11MM S-T SCREW
03662663146258GALLERY 2.0X9MM S-T SCREW
03662663146241GALLERY 2.0X7MM S-T SCREW
03662663146234GALLERY 2.0X5MM S-T SCREW
03662663146227GALLERY PLATE BENDER
03662663146210GALLERY SCREW DRIVER
03662663146203GALLERY STANDARD AWL 2.0MM DIA
036626631461972.4MM X 11MM GALLERY DRILL
036626631461802.4MM X 9MM GALLERY DRILL
036626631461732.4MM X 7MM GALLERY DRILL
036626631461662.4MM X 5MM GALLERY DRILL
03662663146159GALLERY 60 DEGREE PLATE HOLDER
03662663146142GALLERY 25 DEGREE PLATE HOLDER
03662663146135GALLERY QUICK CONNECT HANDLE
0366266314612814MM GALLERY TRIAL
03662663146111GALLERY 12MM TRIAL
03662663146104GALLERY 10MM TRIAL
03662663146098GALLERY 8MM TRIAL
03662663146081SURGICAL TRAY, GALLERY
03662663146623GALLERY 16MM PLATE WITH HOOK
03662663146616GALLERY 14MM PLATE WITH HOOK
03662663146609GALLERY 12MM PLATE WITH HOOK
03662663146593GALLERY 10MM PLATE WITH HOOK
03662663146586GALLERY 8MM PLATE WITH HOOK
03662663146579GALLERY 16MM STANDARD PLATE
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.