AccelFix Spinal Fixation System Instrument Set

GUDID 08809986461193

TM Trial 22x11, H08, A00°

L&K BIOMED CO. ,LTD.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 08809986461193
• NIH Device Record Key: f6cacbc3-3d91-473f-991b-6725a0a1aee2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccelFix Spinal Fixation System Instrument Set
• Version Model Number: PT01-22110800
• Company DUNS: 631159324
• Company Name: L&K BIOMED CO. ,LTD.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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	08809986461193 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[08809986461193]

Moist Heat or Steam Sterilization

[08809986461193]

Moist Heat or Steam Sterilization

[08809986461193]

Moist Heat or Steam Sterilization

[08809986461193]

Moist Heat or Steam Sterilization

[08809986461193]

Moist Heat or Steam Sterilization

[08809986461193]

Moist Heat or Steam Sterilization

[08809986461193]

Moist Heat or Steam Sterilization

[08809986461193]

Moist Heat or Steam Sterilization

[08809986461193]

Moist Heat or Steam Sterilization

[08809986461193]

Moist Heat or Steam Sterilization

[08809986461193]

Moist Heat or Steam Sterilization

[08809986461193]

Moist Heat or Steam Sterilization

[08809986461193]

Moist Heat or Steam Sterilization

[08809986461193]

Moist Heat or Steam Sterilization

[08809986461193]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-07
• Device Publish Date: 2025-02-27

On-Brand Devices [AccelFix Spinal Fixation System Instrument Set]

• 08809986460592: Auxiliary Lower Tray
• 08809986460585: Auxiliary Upper Tray
• 08809986460578: AccelFix-S Auxiliary Container Cover
• 08809986460561: AccelFix-S Auxiliary Container
• 08809986460554: Basic Lower Tray
• 08809986460547: Basic Middle Tray
• 08809986460530: Basic Upper Tray
• 08809986460523: AccelFix-S Basic Container Cover
• 08809986460516: AccelFix-S Basic Container
• 08809986461353: XL Trial 55x18, H12, A12°
• 08809986461346: XL Trial 55x18, H10, A12°
• 08809986461339: XL Trial 55x18, H12, A06°
• 08809986461322: XL Trial 55x18, H10, A06°
• 08809986461315: XL Trial 55x18, H08, A06°
• 08809986461308: TM Trial 22x11, H10, A20°
• 08809986461292: TM Trial 22x11, H10, A15°
• 08809986461285: TM Trial 22x11, H10, A12°
• 08809986461278: TM Trial 22x11, H10, A08°
• 08809986461261: TM Trial 22x11, H10, A04°
• 08809986461254: TM Trial 22x11, H10, A00°
• 08809986461247: TM Trial 22x11, H08, A20°
• 08809986461230: TM Trial 22x11, H08, A15°
• 08809986461223: TM Trial 22x11, H08, A12°
• 08809986461216: TM Trial 22x11, H08, A08°
• 08809986461209: TM Trial 22x11, H08, A04°
• 08809986461193: TM Trial 22x11, H08, A00°