Fuse ULTRA Foot plating System OS421210

GUDID B565OS4212101

10mm Calcaneal Step Plate

CPM MEDICAL CONSULTANTS, LLC

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: B565OS4212101
• NIH Device Record Key: 92fffebc-c045-45e2-85b0-2d1ef4f40888
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fuse ULTRA Foot plating System
• Version Model Number: OS421210
• Catalog Number: OS421210
• Company DUNS: 017138000
• Company Name: CPM MEDICAL CONSULTANTS, 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B565OS4212101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141784

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[B565OS4212101]

Moist Heat or Steam Sterilization

[B565OS4212101]

Moist Heat or Steam Sterilization

[B565OS4212101]

Moist Heat or Steam Sterilization

[B565OS4212101]

Moist Heat or Steam Sterilization

[B565OS4212101]

Moist Heat or Steam Sterilization

[B565OS4212101]

Moist Heat or Steam Sterilization

[B565OS4212101]

Moist Heat or Steam Sterilization

[B565OS4212101]

Moist Heat or Steam Sterilization

[B565OS4212101]

Moist Heat or Steam Sterilization

[B565OS4212101]

Moist Heat or Steam Sterilization

[B565OS4212101]

Moist Heat or Steam Sterilization

[B565OS4212101]

Moist Heat or Steam Sterilization

[B565OS4212101]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-05
• Device Publish Date: 2023-08-28

On-Brand Devices [Fuse ULTRA Foot plating System]

• B565R42260XSR1: MTP Plate Xtra Small Right
• B565R42260XSL1: MTP Plate Xtra Small Left
• B565R42260SR1: MTP Plate Small Right
• B565R42260SL1: MTP Plate Small Left
• B565R42260MR1: MTP Plate Medium Right
• B565R42260ML1: MTP Plate Medium Left
• B565R42260LR1: MTP Plate Large Right
• B565R42260LL1: MTP Plate Large Left
• B565R4218501: 3.5 mm Non-Locking Screw 50mm
• B565R4218451: 3.5 mm Non-Locking Screw 45mm
• B565R4218401: 3.5 mm Non-Locking Screw 40mm
• B565R4218351: 3.5 mm Non-Locking Screw 35mm
• B565R4218301: 3.5 mm Non-Locking Screw 30mm
• B565R4218281: 3.5 mm Non-Locking Screw 28mm
• B565R4218261: 3.5 mm Non-Locking Screw 26mm
• B565R4218241: 3.5 mm Non-Locking Screw 24mm
• B565R4218221: 3.5 mm Non-Locking Screw 22mm
• B565R4218201: 3.5 mm Non-Locking Screw 20mm
• B565R4218181: 3.5 mm Non-Locking Screw 18mm
• B565R4218161: 3.5 mm Non-Locking Screw 16mm
• B565R4218141: 3.5 mm Non-Locking Screw 14mm
• B565R4217501: 3.5mm Locking Screw 50mm
• B565R4217451: 3.5mm Locking Screw 45mm
• B565R4217401: 3.5mm Locking Screw 40mm
• B565R4217351: 3.5mm Locking Screw 35mm
• B565R4217301: 3.5mm Locking Screw 30mm
• B565R4217281: 3.5mm Locking Screw 28mm
• B565R4217261: 3.5mm Locking Screw 26mm
• B565R4217241: 3.5mm Locking Screw 24mm
• B565R4217221: 3.5mm Locking Screw 22mm
• B565R4217201: 3.5mm Locking Screw 20mm
• B565R4217181: 3.5mm Locking Screw 18mm
• B565R4217161: 3.5mm Locking Screw 16mm
• B565R4217141: 3.5mm Locking Screw 14mm
• B565R4217121: 3.5mm Locking Screw 12mm
• B565R4217101: 3.5mm Locking Screw 10mm
• B565R421006R1: Lapidus Plate 6.0mm Right
• B565R421006L1: Lapidus Plate 6.0mm Left
• B565R421004R1: Lapidus Plate 4.0mm Right
• B565R421004L1: Lapidus Plate 4.0mm Left
• B565R421002R1: Lapidus Plate 2.0mm Right
• B565R421002L1: Lapidus Plate 2.0mm Left
• B565R421000R1: Lapidus Plate 0.0mm Right
• B565R421000L1: Lapidus Plate 0.0mm Left
• B565R3279601: 4.0mm 60mm Headless Cannulated Screw
• B565R3279551: 4.0mm 55mm Headless Cannulated Screw
• B565R3279501: 4.0mm 50mm Headless Cannulated Screw
• B565R3279451: 4.0mm 45mm Headless Cannulated Screw
• B565R3279401: 4.0mm 40mm Headless Cannulated Screw
• B565R3279381: 4.0mm 38mm Headless Cannulated Screw