My3D® Personalized Pelvic Reconstruction DG-CS020-04N

GUDID B278DGCS02004N0

4.3MM CANCELLOUS SCREW DRILL GUIDE

ONKOS SURGICAL, INC.

Surgical drill guide, reusable

• Primary Device ID: B278DGCS02004N0
• NIH Device Record Key: 880a3dfb-5da8-4e50-81b8-e7abeee93ba2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: My3D® Personalized Pelvic Reconstruction
• Version Model Number: DG-CS020-04N
• Catalog Number: DG-CS020-04N
• Company DUNS: 080254074
• Company Name: ONKOS SURGICAL, 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B278DGCS02004N0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212815

FDA Product Code

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

Sterilization

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

[B278DGCS02004N0]

Moist Heat or Steam Sterilization

[B278DGCS02004N0]

Moist Heat or Steam Sterilization

[B278DGCS02004N0]

Moist Heat or Steam Sterilization

[B278DGCS02004N0]

Moist Heat or Steam Sterilization

[B278DGCS02004N0]

Moist Heat or Steam Sterilization

[B278DGCS02004N0]

Moist Heat or Steam Sterilization

[B278DGCS02004N0]

Moist Heat or Steam Sterilization

[B278DGCS02004N0]

Moist Heat or Steam Sterilization

[B278DGCS02004N0]

Moist Heat or Steam Sterilization

[B278DGCS02004N0]

Moist Heat or Steam Sterilization

[B278DGCS02004N0]

Moist Heat or Steam Sterilization

[B278DGCS02004N0]

Moist Heat or Steam Sterilization

[B278DGCS02004N0]

Moist Heat or Steam Sterilization

[B278DGCS02004N0]

Moist Heat or Steam Sterilization

[B278DGCS02004N0]

Moist Heat or Steam Sterilization

[B278DGCS02004N0]

Moist Heat or Steam Sterilization

[B278DGCS02004N0]

Moist Heat or Steam Sterilization

[B278DGCS02004N0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-02
• Device Publish Date: 2023-02-22

On-Brand Devices [My3D® Personalized Pelvic Reconstruction ]

• B278DG6512004N0: FLEXIBLE 120MM DEPTH GAUGE
• B278DVRGDMD04N0: RIGID DRILL/SCREW SHAFT, MODULAR
• B278DVFLXMD04N0: FLEXIBLE DRILL/SCREW SHAFT, MODULAR
• B278SF6500004N0: 6.5MM SCREW FORCEPS
• B278HDBP33204N0: BALL PUSHER
• B278EX3506504N0: CONICAL SCREW EXTRACTOR, 4.5 -7.0MM SCREWS, AO CONNECTION
• B278TP65180040: 6.5MM x 180MM CANCELLOUS BONE SCREW TAP, AO CONNECTOR
• B278TP6505004N0: 6.5MM x 50MM CANCELLOUS BONE SCREW TAP, BAYONET CONNETOR
• B278TP6502504N0: 6.5MM x 25MM CANCELLOUS BONE SCREW TAP, BAYONET CONNECTOR
• B278PVGUIDE04N0: Customized Pelvic Guide
• B278PVAPRCN04M0: Advanced Pelvic Reconstruction Implant
• B278PVACREC04M0: Acetabular Reconstruction Implant
• B278HDSP03604N0: Pelvic Impactor
• B278HD35TRQ04N0: TORQUE LIMITING ZSJ HALL HANDLE, 35IN-LBS
• B278DGCS02004N0: 4.3MM CANCELLOUS SCREW DRILL GUIDE
• B278AMM3DMD04N0: Anatomic Model
• B278AMC3DMD04N0: Clear Anatomic Model
• B278PN3208904N0: 3.2 x 89MM Smooth Trocar Tip Pin
• B278DR4350N04N0: 4.3MM x 50MM Non-Sterile Modular Drill Bit
• B278DR432NS04N0: 4.3MM x 200MM Non-Sterile Calibrated Drill Bit
• B278DR4325N04N0: 4.3MM x 25MM Non-Sterile Modular Drill Bit
• B278LS5003504M0: Locking Cortical Bone Screw 5.0x35MM
• B278LS5003004M0: Locking Cortical Bone Screw 5.0x30MM
• B278LS5001604M0: Locking Cortical Bone Screw 5.0x16MM
• B278LS5001504M0: Locking Cortical Bone Screw 5.0x15MM
• B278LS5001404M0: Locking Cortical Bone Screw 5.0x14MM
• B278LS5001204M0: Locking Cortical Bone Screw 5.0x12MM
• B278LS5001004M0: Locking Cortical Bone Screw 5.0x10MM
• B278DR4320004N0: 4.3 x 200MM Calibrated Drill Bit
• B278DR4305004N0: 4.3 x 50MM Modular Drill Bit
• B278DR4302504N0: 4.3 x 25MM Modular Drill Bit
• B278LS5009504M0: Locking Cortical Bone Screw 5.0x95MM
• B278LS5009004M0: Locking Cortical Bone Screw 5.0x90MM
• B278LS5008504M0: Locking Cortical Bone Screw 5.0x85MM
• B278LS5008004M0: Locking Cortical Bone Screw 5.0x80MM
• B278LS5007504M0: Locking Cortical Bone Screw 5.0x75MM
• B278LS5007004M0: Locking Cortical Bone Screw 5.0x70MM
• B278LS5006504M0: Locking Cortical Bone Screw 5.0x65MM
• B278LS5006004M0: Locking Cortical Bone Screw 5.0x60MM
• B278LS5005504M0: Locking Cortical Bone Screw 5.0x55MM
• B278LS5005004M0: Locking Cortical Bone Screw 5.0x50MM
• B278LS5004804M0: Locking Cortical Bone Screw 5.0x48MM
• B278LS5004504M0: Locking Cortical Bone Screw 5.0x45MM
• B278LS5004404M0: Locking Cortical Bone Screw 5.0x44MM
• B278LS5004204M0: Locking Cortical Bone Screw 5.0x42MM
• B278LS5004004M0: Locking Cortical Bone Screw 5.0x40MM
• B278LS5003804M0: Locking Cortical Bone Screw 5.0x38MM
• B278LS5003604M0: Locking Cortical Bone Screw 5.0x36MM
• B278LS5003404M0: Locking Cortical Bone Screw 5.0x34MM
• B278LS5003204M0: Locking Cortical Bone Screw 5.0x32MM