Illico

GUDID 00190376002521

Reduction Polyaxial Screw Driver, NI

ALPHATEC SPINE, INC.

Surgical screwdriver, reusable

• Primary Device ID: 00190376002521
• NIH Device Record Key: f92472ac-84c2-463a-8a74-14f90ebf77be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Illico
• Version Model Number: 73768
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, 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

Customer Support Contacts

• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376002521 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153603

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00190376002521]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-03
• Device Publish Date: 2016-09-14

On-Brand Devices [Illico]

• 00190376002644: 8.5 mm Cannulated Tap, NI
• 00190376002620: 7.5 mm Cannulated Tap, NI
• 00190376002606: 6.5 mm Cannulated Tap, NI
• 00190376002583: 5.5 mm Cannulated Tap, NI
• 00190376002552: 4.5 mm Cannulated Tap, NI
• 00190376002521: Reduction Polyaxial Screw Driver, NI
• 00190376002484: Polyaxial Screw Driver, NI
• 00844856021587: Illico Suction #10
• 00844856021570: Illico Suction #8
• 00844856057661: THREADED TIP NITINOL GUIDEWIRE 20"
• 00844856057654: BLUNT TIP NITINOL GUIDEWIRE 20"
• 00844856057647: TROCAR TIP NITINOL GUIDEWIRE 20"
• 00844856057630: THREADED TIP NITINOL GUIDEWIRE 17.75"
• 00844856057623: BLUNT TIP NITINOL GUIDEWIRE 17.75"
• 00844856057616: TROCAR TIP NITINOL GUIDEWIRE 17.75"
• 00844856053809: TARGETING NEEDLE, 11G, STERILE PACKAGED
• 00844856043930: STAINLESS STEEL GUIDEWIRE
• 00840967192895: BLUNT, THREADED TIP NITINOL GUIDEWIRE 25"
• 00840967192888: THREADED TIP NITINOL GUIDEWIRE 25"
• 00840967192871: BLUNT TIP NITINOL GUIDEWIRE 25"
• 00840967192864: TROCAR TIP NITINOL GUIDEWIRE 25"
• 00840967192857: Blunt, Threaded Tip Nitinol Guidewire 20"
• 00840967192840: Blunt, Threaded Tip Nitinol Guidewire 17.75"
• 00190376275697: ILLICO SE MIS POSTERIOR FIXATION SYSTEM_x001E__x001E_
• 00190376275680: ILLICO RETRACTOR
• 00190376275673: ILLICO PDP
• 00190376275666: ILLICO NAVIGATION TRAY
• 00190376275659: ILLICO ML (MULTI-LEVEL) WIDE EXTENDER
• 00190376275642: ILLICO ML (MULTI-LEVEL) STANDARD EXTENDERS
• 00190376275635: ILLICO MIS INSTRUMENTS
• 00190376275628: ILLICO MIS CANNULATED IMPLANTS TI
• 00190376275611: ILLICO FS Facet Screw Instrument/Implant
• 00190376275604: ILLICO FS Facet Lag Screw Instr/Impl Set
• 00844856042605: SE DILATOR 4
• 00844856042599: SE DILATOR 3
• 00844856042575: SE DILATOR 1
• 00844856021419: ILLICO 2mm FORAMANOTOMY KERRISON. BAYONETED
• 00844856021372: ILLICO 5mm KERRISON 90 DEG. BAYONETED
• 00844856021365: ILLICO 4mm KERRISON 90 DEG. BAYONETED
• 00844856021358: ILLICO 3mm KERRISON 90 DEG. BAYONETED
• 00844856021341: ILLICO 2mm KERRISON 90 DEG. BAYONETED
• 00844856021334: ILLICO 5mm KERRISON 40 DEG. BAYONETED
• 00844856021327: ILLICO 4mm KERRISON 40 DEG. BAYONETED
• 00844856021310: ILLICO 3mm KERRISON 40 DEG. BAYONETED
• 00844856021303: ILLICO 2mm KERRISON 40 DEG. BAYONETED
• 00844856021037: ILLICO BLUNT PIN
• 00844856021020: ILLICO DILATOR 3
• 00844856021013: ILLICO DILATOR 2
• 00844856021006: ILLICO DILATOR 1
• 00840967192819: ILLICO SE DILATOR IM 2