37mm W X 28mm D X 18mm H, 20°, PILLAR SA Ti, STERILE

GUDID 18257200161010

Orthofix US LLC

Metallic spinal interbody fusion cage
Primary Device ID18257200161010
NIH Device Record Key33c281dc-5edd-4a52-b06a-5d8c08585a69
Commercial Distribution StatusIn Commercial Distribution
Brand Name37mm W X 28mm D X 18mm H, 20°, PILLAR SA Ti, STERILE
Version Model Number82-3713SP
Company DUNS927083808
Company NameOrthofix US LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
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

Customer Support Contacts

Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS118257200161010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-25
Device Publish Date2025-07-17

Devices Manufactured by Orthofix US LLC

18257200161010 - 37mm W X 28mm D X 18mm H, 20°, PILLAR SA Ti, STERILE2025-07-25
18257200161010 - 37mm W X 28mm D X 18mm H, 20°, PILLAR SA Ti, STERILE2025-07-25
18257200140121 - Firebird SI Fusion2025-04-10 11MM X 50MM FIREBIRD SI SCREW, FIREBIRD SI FUSION SYSTEM, STERILE
18257200140138 - Firebird SI Fusion2025-04-10 11MM X 55MM FIREBIRD SI SCREW, FIREBIRD SI FUSION SYSTEM, STERILE
18257200140145 - Firebird SI Fusion2025-04-10 11MM X 60MM FIREBIRD SI SCREW, FIREBIRD SI FUSION SYSTEM, STERILE
18257200140152 - Firebird SI Fusion2025-04-10 11MM X 65MM FIREBIRD SI SCREW, FIREBIRD SI FUSION SYSTEM, STERILE
18257200140169 - Firebird SI Fusion2025-04-10 11MM X 70MM FIREBIRD SI SCREW, FIREBIRD SI FUSION SYSTEM, STERILE
18257200140176 - Firebird SI Fusion2025-04-10 12MM X 25MM FIREBIRD SI SCREW, FIREBIRD SI FUSION SYSTEM, STERILE
18257200140183 - Firebird SI Fusion2025-04-10 12MM X 30MM FIREBIRD SI SCREW, FIREBIRD SI FUSION SYSTEM, STERILE

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