OrthoMedFlex 111-21-2859

GUDID M7161112128590

Bipolar Head size 59

ORTHOMEDFLEX LLC

Bipolar femoral head outer component, hemiarthroplasty

• Primary Device ID: M7161112128590
• NIH Device Record Key: b36ba8b7-fee8-4d84-897c-53c2c2ade2f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoMedFlex
• Version Model Number: 111212859
• Catalog Number: 111-21-2859
• Company DUNS: 034442726
• Company Name: ORTHOMEDFLEX LLC
• 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: true
• 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
HIBCC	M7161112128590 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133370

FDA Product Code

• KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or 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: 2
• Public Version Date: 2020-09-09
• Device Publish Date: 2019-02-18

On-Brand Devices [OrthoMedFlex]

• M7161121525260: Trial Liner 20° 36/60-70 (E)
• M7161121525250: Trial Liner 20° 36/56-58 (D)
• M7161121525240: Trial Liner 20° 36/52-54 (C)
• M7161121525230: Trial Liner 20° 32/60-70 (E)
• M7161121525220: Trial Liner 20° 32/56-58 (D)
• M7161121525210: Trial Liner 20° 32/52-54 (C)
• M7161121525200: Trial Liner 20° 32/48-50 (B)
• M7161121525190: Trial Liner 20° 28/52-54 (C)
• M7161121525180: Trial Liner 20° 28/48-50 (B)
• M7161121525170: Trial Liner 20° 28/44-46 (A)
• M7161121525160: Trial Liner 20° 22/40-42
• M7161121588520: Trial Liner, 28/52-54C (+4 10° Hooded Lateralised)
• M7161121588500: Trial Liner, 28/48-50B (+4 10° Hooded Lateralised)
• M7161121588440: Trial Liner, 28/44-46A (+4 10° Hooded Lateralised)
• M7161121586600: Trial Liner, 36/60-68E (+4 10° Hooded Lateralised)
• M7161121586560: Trial Liner, 36/56-58D (+4 10° Hooded Lateralised)
• M7161121586520: Trial Liner, 36/52-54C (+4 10° Hooded Lateralised)
• M7161121582600: Trial Liner, 32/60-68E (+4 10° Hooded Lateralised)
• M7161121582560: Trial Liner, 32/56-58D (+4 10° Hooded Lateralised)
• M7161121582520: Trial Liner, 32/52-54C (+4 10° Hooded Lateralised)
• M7161121582500: Trial Liner, 32/48-50B (+4 10° Hooded Lateralised)
• M7161121582400: Trial Liner, 22/40-42 (+4 10° Hooded Lateralised)
• M7161121578520: Trial Liner, 28/52-54C (+4 Neutral Lateralised)
• M7161121578500: Trial Liner, 28/48-50B (+4 Neutral Lateralised)
• M7161121578440: Trial Liner, 28/44-46A (+4 Neutral Lateralised)
• M7161121576600: Trial Liner, 36/60-68E (+4 Neutral Lateralised)
• M7161121576560: Trial Liner, 36/56-58D (+4 Neutral Lateralised)
• M7161121576520: Trial Liner, 36/52-54C (+4 Neutral Lateralised)
• M7161121572600: Trial Liner, 32/60-68E (+4 Neutral Lateralised)
• M7161121572560: Trial Liner, 32/56-58D (+4 Neutral Lateralised)
• M7161121572520: Trial Liner, 32/52-54C (+4 Neutral Lateralised)
• M7161121572500: Trial Liner, 32/48-50B (+4 Neutral Lateralised)
• M7161121572400: Trial Liner, 22/40-42 (+4 Neutral Lateralised)
• M7161122500790: Femoral Head Extractor Long
• M7161122500380: Femoral Head Extractor
• M7161122401010: Bipolar Head Inserter
• M716101144010: Thread Adaptor
• M7161011410: Femoral Head Extractor
• M716AL2361560: Tryon Acetabular Cup Liner, Neutral, SIZE 36/56-58mm XL - UHMWPE
• M716AFS65200: Tryon Acetabular Bone Screw, SIZE 20mm Ti6AI4V Alloys
• M7161111243680: 68mm Acetabular Cup (3-Hole) HA
• M7161111243660: 66mm Acetabular Cup (3-Hole) HA
• M7161111243640: 64mm Acetabular Cup (3-Hole) HA
• M7161111243620: 62mm Acetabular Cup (3-Hole) HA
• M7161111243600: 60mm Acetabular Cup (3-Hole) HA
• M7161111243580: 58mm Acetabular Cup (3-Hole) HA
• M7161111243560: 56mm Acetabular Cup (3-Hole) HA
• M7161111243540: 54mm Acetabular Cup (3-Hole) HA
• M7161111243520: 52mm Acetabular Cup (3-Hole) HA
• M7161111243500: 50mm Acetabular Cup (3-Hole) HA