Accufuse Cervical System 10-10

GUDID 00810016800903

Torque Limiter Handle -13 in.lbs/1.5 N-m

ABSOLUTE ADVANTAGE MEDICAL, LLC

Surgical instrument torque limiter

• Primary Device ID: 00810016800903
• NIH Device Record Key: 0cdd8311-6f8e-4b1d-87f6-8e7f32e28960
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accufuse Cervical System
• Version Model Number: 10-10
• Catalog Number: 10-10
• Company DUNS: 056248579
• Company Name: ABSOLUTE ADVANTAGE MEDICAL, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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
GS1	00810016800903 [Primary]

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00810016800903]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-02
• Device Publish Date: 2019-04-24

On-Brand Devices [Accufuse Cervical System]

• 00810016801207: Case - Lid
• 00810016800309: Cervical Screw Variable 4.5x14mm Sharp
• 00810016801269: Variable Screw Implant Caddy with Lid
• 00810016801252: Fixed Screw Implant Caddy with Lid
• 00810016801245: Plate Implant Caddy with Lid
• 00810016801238: Cage Implant Caddy with Lid
• 00810016801221: Case Implant Tray
• 00810016801214: Case Base Instrument Tray
• 00810016801191: System Case
• 00810016801184: Cage - Plate Trial 12mm
• 00810016801177: Cage - Plate Trial 11mm
• 00810016801160: Cage - Plate Trial 10mm
• 00810016801153: Cage - Plate Trial 9mm
• 00810016801146: Cage - Plate Trial 8mm
• 00810016801139: Cage - Plate Trial 7mm
• 00810016801122: Cage - Plate Trial 6mm
• 00810016801115: Cage - Plate Trial 5mm
• 00810016801108: Cover Plate Sheath
• 00810016801092: Dual Drill Guide - Angled
• 00810016801085: Cage Plate Fastener
• 00810016801078: Cage Tamp
• 00810016801061: Cage Trial 12mm
• 00810016801054: Cage Trial 11mm
• 00810016801047: Cage Trial 10mm
• 00810016801030: Cage Trial 9mm
• 00810016801023: Cage Trial 8mm
• 00810016801016: Cage Trial 7mm
• 00810016801009: Cage Trial 6mm
• 00810016800996: Cage Trial 5mm
• 00810016800989: Dual Drill Guide Block-14mm Plate
• 00810016800972: Dual Drill Guide Block-13mm Plate
• 00810016800965: Dual Drill Guide Block-12mm Plate
• 00810016800958: Dual Drill Guide Block-11mm Plate
• 00810016800941: Dual Drill Guide Block-10mm Plate
• 00810016800934: Dual Drill Guide Block-9mm Plate
• 00810016800927: Dual Drill Guide Block-8mm Plate
• 00810016800910: Dual Drill Guide Block-7mm Plate
• 00810016800903: Torque Limiter Handle -13 in.lbs/1.5 N-m
• 00810016800897: Screw Driver - Hexalobe #15
• 00810016800880: Cage Only Inserter
• 00810016800873: Dual Drill Guide, Straight
• 00810016800866: Single Drill Guide, Variable
• 00810016800859: Small AO Chuck Handle-Non Ratchet
• 00810016800842: Bone Tap Ø4.0x12mm
• 00810016800835: Drill Bit Ø2.4x16mm
• 00810016800828: Drill Bit Ø2.4x14mm
• 00810016800811: Drill Bit Ø2.4x12mm
• 00810016800804: Bone Awl, Open
• 00810016800798: Cervical PEEK 14mmx12mmx12mm 7° lordosis
• 00810016800781: Cervical PEEK 14mmx12mmx10mm 7° lordosis