Anterior Bone Impactor 7439-54

GUDID 10840199500588

Anterior Bone Impactor Tip Size 10x14mm length 37cm

KOROS U.S.A., INC.

External spinal fixation system

• Primary Device ID: 10840199500588
• NIH Device Record Key: 9dc47c78-0cce-4b72-81f8-05c5f4dcd7f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anterior Bone Impactor
• Version Model Number: 7439-54
• Catalog Number: 7439-54
• Company DUNS: 007928633
• Company Name: KOROS U.S.A., 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: true
• 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: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840199500581 [Direct Marking]
GS1	10840199500588 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K875290

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

[10840199500588]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-08
• Device Publish Date: 2022-01-31

On-Brand Devices [Anterior Bone Impactor]

• 10840199500557: Anterior Bone Impactor Tip Size 9x16mm length 34cm
• 00840199527229: Anterior Bone Impactor 7 x 16mm Tip, 13-1/2" 34cm Length
• 10840199500601: Anterior Bone Impactor Tip Size 15x19.5mm length 37cm
• 10840199500595: Anterior Bone Impactor Tip Size 15x19.5mm length 37cm
• 10840199500588: Anterior Bone Impactor Tip Size 10x14mm length 37cm
• 10840199500571: Anterior Bone Impactor Tip Size 10x14mm length 37cm
• 10840199500564: Anterior Bone Impactor Tip Size 9x23mm length 34cm