Dyna-EXTOR Ⅱ EXTERNAL FIXATION SYSTEM

GUDID 08809155851350

Dyna-EXTOR(L) Ⅱ, Single Clamp

BK MEDITECH CO.,LTD.

External orthopaedic fixation system, single-use

• Primary Device ID: 08809155851350
• NIH Device Record Key: c4052868-5687-49e0-be89-3f43a8e2028c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dyna-EXTOR Ⅱ EXTERNAL FIXATION SYSTEM
• Version Model Number: 22610
• Company DUNS: 687941818
• Company Name: BK MEDITECH CO.,LTD.
• 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: true
• 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
GS1	08809155851350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110426

FDA Product Code

• KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

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

[08809155851350]

Moist Heat or Steam Sterilization

[08809155851350]

Moist Heat or Steam Sterilization

[08809155851350]

Moist Heat or Steam Sterilization

[08809155851350]

Moist Heat or Steam Sterilization

[08809155851350]

Moist Heat or Steam Sterilization

[08809155851350]

Moist Heat or Steam Sterilization

[08809155851350]

Moist Heat or Steam Sterilization

[08809155851350]

Moist Heat or Steam Sterilization

[08809155851350]

Moist Heat or Steam Sterilization

[08809155851350]

Moist Heat or Steam Sterilization

[08809155851350]

Moist Heat or Steam Sterilization

[08809155851350]

Moist Heat or Steam Sterilization

[08809155851350]

Moist Heat or Steam Sterilization

[08809155851350]

Moist Heat or Steam Sterilization

[08809155851350]

Moist Heat or Steam Sterilization

[08809155851350]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-11-23
• Device Publish Date: 2015-09-22

On-Brand Devices [Dyna-EXTOR Ⅱ EXTERNAL FIXATION SYSTEM]

• 08809155852531: Dyna-EXTOR(ST) Ⅱ, 3.0cm
• 08809155852524: Dyna-EXTOR(ST) Ⅱ, 3.6cm
• 08809155852517: Dyna-EXTOR(ST) Ⅱ, 7.0cm
• 08809155852500: Dyna-EXTOR(ST) Ⅱ, 6.0cm
• 08809155852050: Dyna-EXTOR(SM) Ⅱ, Forearm
• 08809155852043: Dyna-EXTOR(SM) Ⅱ, 11cm
• 08809155852036: Dyna-EXTOR(SM) Ⅱ, 8cm
• 08809155851640: Dyna-EXTOR(M) Ⅱ, Lengthening Bar
• 08809155851633: Dyna-EXTOR(M) Ⅱ, T Clamp
• 08809155851626: Dyna-EXTOR(M) Ⅱ, Stnadard Clamp
• 08809155851619: Dyna-EXTOR(M) Ⅱ, T-Type
• 08809155851602: Dyna-EXTOR(M) Ⅱ, Standard-Type
• 08809155851589: Dyna-EXTOR(M) Ⅱ, Al Bar, 11cm
• 08809155851572: Dyna-EXTOR(M) Ⅱ, Al Bar, 14cm
• 08809155851558: Dyna-EXTOR(M) Ⅱ, Bar Ring Connector
• 08809155851541: Dyna-EXTOR(M) Ⅱ, Single Clamp
• 08809155851381: Dyna-EXTOR(L) Ⅱ, Simple Clamp
• 08809155851374: Dyna-EXTOR(L) Ⅱ, Bar Ring Connector
• 08809155851367: Dyna-EXTOR(L) Ⅱ, Arch Plate
• 08809155851350: Dyna-EXTOR(L) Ⅱ, Single Clamp
• 08809155851343: Dyna-EXTOR(L) Ⅱ, Ankle Clamp
• 08809155851336: Dyna-EXTOR(L) Ⅱ, Lengthening Bar(L)
• 08809155851329: Dyna-EXTOR(L) Ⅱ, Lengthening Bar(S)
• 08809155851312: Dyna-EXTOR(L) Ⅱ, Bar-Ring Clamp
• 08809155851305: Dyna-EXTOR(L) Ⅱ, T Clamp
• 08809155851299: Dyna-EXTOR(L) Ⅱ, Standard Clamp
• 08809155851282: Dyna-EXTOR(L) Ⅱ, T-Type
• 08809155851275: Dyna-EXTOR(L) Ⅱ, Standard-Type
• 08809155851251: Dyna-EXTOR(L) Ⅱ, Bar to Bar Connector