ONVOY

GUDID 00193982649272

BIOLOX delta Femoral Head, 40mm +3.5

GLOBUS MEDICAL, INC.

Polyethylene acetabulum prosthesis

• Primary Device ID: 00193982649272
• NIH Device Record Key: d7921de3-8d7c-4341-937f-334fe795e7b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONVOY
• Version Model Number: 5235.5404S
• Company DUNS: 139105691
• Company Name: GLOBUS MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00193982649272 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243456

FDA Product Code

• OQG: Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-22
• Device Publish Date: 2025-07-14

On-Brand Devices [ONVOY]

• 00193982454562: Abduction Alignment Guide - 45 Deg
• 00193982454555: Acetabular Shell Inserter - Straight
• 00193982464578: ONVOY Acetabular Bone Screw, 6.5mmx60mm
• 00193982464561: ONVOY Acetabular Bone Screw, 6.5mmx50mm
• 00193982464554: ONVOY Acetabular Bone Screw, 6.5mmx40mm
• 00193982464547: ONVOY Acetabular Bone Screw, 6.5mmx35mm
• 00193982464530: ONVOY Acetabular Bone Screw, 6.5mmx30mm
• 00193982464523: ONVOY Acetabular Bone Screw, 6.5mmx25mm
• 00193982464516: ONVOY Acetabular Bone Screw, 6.5mmx20mm
• 00193982464509: ONVOY Acetabular Bone Screw, 6.5mmx15mm
• 00193982649272: BIOLOX delta Femoral Head, 40mm +3.5
• 00193982649258: BIOLOX delta Femoral Head, 40mm +0
• 00193982649227: BIOLOX delta Femoral Head, 22mm +0
• 00193982649210: ONVOY Dual Mobility Poly Bearing EXp+, 28mm ID, 55mm OD
• 00193982649203: ONVOY Dual Mobility Poly Bearing EXp+, 28mm ID, 51mm OD
• 00193982649197: ONVOY Dual Mobility Poly Bearing EXp+, 28mm ID, 47mm OD
• 00193982649180: ONVOY Dual Mobility Poly Bearing EXp+, 28mm ID, 43mm OD
• 00193982649173: ONVOY Dual Mobility Poly Bearing EXp+, 28mm ID, 39mm OD
• 00193982649166: ONVOY Dual Mobility Poly Bearing EXp+, 28mm ID, 37mm OD
• 00193982649159: ONVOY Dual Mobility Poly Bearing EXp+, 22mm ID, 55mm OD
• 00193982649142: ONVOY Dual Mobility Poly Bearing EXp+, 22mm ID, 51mm OD
• 00193982649135: ONVOY Dual Mobility Poly Bearing EXp+, 22mm ID, 47mm OD
• 00193982649128: ONVOY Dual Mobility Poly Bearing EXp+, 22mm ID, 43mm OD
• 00193982649111: ONVOY Dual Mobility Poly Bearing EXp+, 22mm ID, 39mm OD
• 00193982649104: ONVOY Dual Mobility Poly Bearing EXp+, 22mm ID, 37mm OD
• 00193982649098: ONVOY Dual Mobility Poly Bearing EXp+, 22mm ID, 35mm OD
• 00193982649081: ONVOY Acetabular EXp+ Liner, Lateralized, 40mm ID, 72-74 OD
• 00193982649074: ONVOY Acetabular EXp+ Liner, Lateralized, 40mm ID, 66-70 OD
• 00193982649067: ONVOY Acetabular EXp+ Liner, Lateralized, 40mm ID, 62-64 OD
• 00193982649050: ONVOY Acetabular EXp+ Liner, Lateralized, 40mm ID, 58-60 OD
• 00193982649043: ONVOY Acetabular EXp+ Liner, Lateralized, 40mm ID, 54-56 OD
• 00193982649036: ONVOY Acetabular EXp+ Liner, Lateralized, 36mm ID, 72-74 OD
• 00193982649029: ONVOY Acetabular EXp+ Liner, Lateralized, 36mm ID, 66-70 OD
• 00193982649012: ONVOY Acetabular EXp+ Liner, Lateralized, 36mm ID, 62-64 OD
• 00193982649005: ONVOY Acetabular EXp+ Liner, Lateralized, 36mm ID, 58-60 OD
• 00193982648992: ONVOY Acetabular EXp+ Liner, Lateralized, 36mm ID, 54-56 OD
• 00193982648985: ONVOY Acetabular EXp+ Liner, Lateralized, 36mm ID, 50-52 OD
• 00193982648978: ONVOY Acetabular EXp+ Liner, Lateralized, 32mm ID, 72-74 OD
• 00193982648961: ONVOY Acetabular EXp+ Liner, Lateralized, 32mm ID, 66-70 OD
• 00193982648954: ONVOY Acetabular EXp+ Liner, Lateralized, 32mm ID, 62-64 OD
• 00193982648947: ONVOY Acetabular EXp+ Liner, Lateralized, 32mm ID, 58-60 OD
• 00193982648930: ONVOY Acetabular EXp+ Liner, Lateralized, 32mm ID, 54-56 OD
• 00193982648923: ONVOY Acetabular EXp+ Liner, Lateralized, 32mm ID, 50-52 OD
• 00193982648916: ONVOY Acetabular EXp+ Liner, Lateralized, 32mm ID, 48 OD
• 00193982648909: ONVOY Acetabular EXp+ Liner, Lateralized, 32mm ID, 46 OD
• 00193982648893: ONVOY Acetabular EXp+ Liner, Lateralized, 28mm ID, 72-74 OD
• 00193982648886: ONVOY Acetabular EXp+ Liner, Lateralized, 28mm ID, 66-70 OD
• 00193982648879: ONVOY Acetabular EXp+ Liner, Lateralized, 28mm ID, 62-64 OD
• 00193982648862: ONVOY Acetabular EXp+ Liner, Lateralized, 28mm ID, 58-60 OD
• 00193982648855: ONVOY Acetabular EXp+ Liner, Lateralized, 28mm ID, 54-56 OD