OrthoMedFlex, LLC AH1-540

GUDID M716AH15400

Femoral Head, SIZE 40mm (XL) CoCr Alloy (+10mm)

ORTHOMEDFLEX LLC

Metallic femoral head prosthesis

• Primary Device ID: M716AH15400
• NIH Device Record Key: 64ab944b-9e94-4ef4-bc1b-877167f6d045
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoMedFlex, LLC
• Version Model Number: AH1-540
• Catalog Number: AH1-540
• Company DUNS: 034442726
• Company Name: ORTHOMEDFLEX LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Customer Support Contacts

• Phone: 1-844-663-3539
• Email: info@orthomedflex.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M716AH15400 [Primary]

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-04-06
• Device Publish Date: 2017-04-25

On-Brand Devices [OrthoMedFlex, LLC]

• M7161121584600: Trial Liner, 40/60-68E (+4 10° Hooded Lateralised)
• M7161121584560: Trial Liner, 40/56-58D (+4 10° Hooded Lateralised)
• M7161121574600: Trial Liner, 40/60-68E (+4 Neutral Lateralised)
• M7161121574560: Trial Liner, 40/56-58D (+4 Neutral Lateralised)
• M7161111526440: Ceramic Femoral Head, 40mm +8mm (XL)
• M716AH15400: Femoral Head, SIZE 40mm (XL) CoCr Alloy (+10mm)
• M716AH14400: Femoral Head, SIZE 40mm (XL) CoCr Alloy
• M716AH13400: Femoral Head SIZE 40mm, (L) CoCr Alloy
• M716AH12400: Femoral Head, SIZE 40mm (M) CoCr Alloy
• M716AH11400: Femoral Head, SIZE 40mm, (S) CoCr Alloy
• M7161111912010: Orion Stem, H/O (Lateralized), - Size 12
• M7161111912000: Orion Stem, Standard Offset, Size 12
• M7161122800370: Stepped Reamer
• M7161013140: Curved Reamer Assembly
• M716101199S0: Quick Connect Drill Bit, 35mm (Sterile)
• M716101198S0: Quick Connect Drill Bit (sterile)
• M7161011350: IM Drill Reamer
• M7161011220: Tapered Pin Reamer
• M7161011200: Stepped Entry Reamer
• M716AH34400: Ceramic Femoral Head, 40mm +8.0mm (XL)
• M716AH33400: Cermaic Femoral Head, 40mm +4.0mm (L)
• M716AH32400: Ceramic Femoral Head, 40mm +0.0mm (M)
• M716AH31400: Ceramic Femoral Head, 40mm -4.0mm (S)
• M716101661020: Non-Cemented Stem Magazine Insert - Orion
• M716101661010: Non-Cemented Stem Magazine Insert - Kratos
• M7161016610: Super Tray with Kratos & Orion Inserts
• M7161016600: Mudbox Tray used for transporting miscellaneous instruments.
• M7161121525280: Trial Liner, 40/60-68E (20 degree Hooded)
• M7161121525270: Trial Liner, 40/56-58D (20 degree Hooded)
• M7161121521670: Trial Liner, 40/60-68E (Neutral)
• M7161121521660: Trial Liner, 40/56-58D (Neutral)
• M7161121521430: Trial Liner, 40/60-68E (10 degree Hooded)
• M7161121521420: Trial Liner, 40/56-58D (10 degree Hooded)
• M7161013450: Femoral Rasp