InCore Lapidus

GUDID 00817701021261

Removal Drill Guide Reusable

NEXTREMITY SOLUTIONS, INC.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00817701021261
• NIH Device Record Key: b38682a1-d7cb-419d-9739-e25dcd924f45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InCore Lapidus
• Version Model Number: IC-LAP-0117
• Company DUNS: 060783407
• Company Name: NEXTREMITY SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817701021261 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

[00817701021261]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-24
• Device Publish Date: 2018-08-23

On-Brand Devices [InCore Lapidus]

• 00817701021384: InCore Lapidus Torque Limiting Handle
• 00817701021353: Lapidus Replacement Compression Screw Reusable
• 00817701021346: Lapidus Replacement Compression Frame Reusable
• 00817701021322: Instrument Case Lid Reusable
• 00817701021315: Instrument Case Reusable
• 00817701021308: Ratchet Handle Reusable
• 00817701021292: Depth Probe Reusable
• 00817701021285: Removal Fastener Reusable
• 00817701021278: Removal Slap Hammer Reusable
• 00817701021261: Removal Drill Guide Reusable
• 00817701021254: 3.6mm Drill Bit Reusable
• 00817701021247: T10 Driver Reusable
• 00817701021230: 5.9mm Post Drill Reusable
• 00817701021223: Post Fastener Reusable
• 00817701021216: Drill Bushing 70mm Reusable
• 00817701021209: Drill Bushing 55mm Reusable
• 00817701021193: Drill Bushing 40mm Reusable
• 00817701021186: 2mm X 4" K-Wire
• 00817701021179: Targeting Guide Assembly Right Reusable
• 00817701021162: Targeting Guide Assembly Left Reusable
• 00817701021155: Post Guide Right Reusable
• 00817701021148: Post Guide Left Reusable
• 00817701021131: InCore Lapidus Post Plug Screw
• 00817701021124: InCore Lapidus 3.5mm X 46mm Titanium Screw
• 00817701021117: InCore Lapidus 3.5mm X 60mm Titanium Screw
• 00817701021100: InCore Lapidus 3.5mm X 58mm Titanium Screw
• 00817701021094: InCore Lapidus 3.5mm X 56mm Titanium Screw
• 00817701021087: InCore Lapidus 3.5mm X 54mm Titanium Screw
• 00817701021070: InCore Lapidus 3.5mm X 52mm Titanium Screw
• 00817701021063: InCore Lapidus 3.5mm X 50mm Titanium Screw
• 00817701021056: InCore Lapidus 3.5mm X 48mm Titanium Screw
• 00817701021049: InCore Lapidus 3.5mm X 44mm Titanium Screw
• 00817701021032: InCore Lapidus 3.5mm X 42mm Titanium Screw
• 00817701021025: InCore Lapidus 3.5mm X 40mm Titanium Screw
• 00817701021018: InCore Lapidus 3.5mm X 38mm Titanium Screw
• 00817701021001: InCore Lapidus 3.5mm X 36mm Titanium Screw
• 00817701020998: InCore Lapidus 3.5mm X 34mm Titanium Screw
• 00817701020981: InCore Lapidus 3.5mm X 32mm Titanium Screw
• 00817701020974: InCore Lapidus 3.5mm X 30mm Titanium Screw
• 00817701020967: InCore Lapidus 3.5mm X 28mm Titanium Screw
• 00817701020950: InCore Lapidus 3.5mm X 26mm Titanium Screw
• 00817701020943: InCore Lapidus 3.5mm X 24mm Titanium Screw
• 00817701020936: InCore Lapidus 5.9mm X 32mm Left Titanium Post
• 00817701020929: InCore Lapidus 5.9mm X 32mm Right Titanium Post
• 00817701020912: InCore Lapidus 5.9mm X 28mm Left Titanium Post
• 00817701020905: InCore Lapidus 5.9mm X 28mm Right Titanium Post
• 00817701020899: InCore Lapidus 5.9mm X 32mm Left Kit
• 00817701020882: IC-LAP-32R
• 00817701020875: InCore Lapidus 5.9mm X 28mm Left Kit
• 00817701020868: InCore Lapidus 5.9mm X 28mm Right Kit