PolyLock SmallBone SB-TP-9005

GUDID 00840124507111

T-Plate Revision Compression 5 Hole

FUSION ORTHOPEDICS, LLC

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 00840124507111
• NIH Device Record Key: a7e238ca-476c-42f7-a646-c63f7ee7bc6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PolyLock SmallBone
• Version Model Number: SB-TP-9005
• Catalog Number: SB-TP-9005
• Company DUNS: 080307067
• Company Name: FUSION ORTHOPEDICS, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: true
• 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	00840124507111 [Primary]

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[00840124507111]

Moist Heat or Steam Sterilization

[00840124507111]

Moist Heat or Steam Sterilization

[00840124507111]

Moist Heat or Steam Sterilization

[00840124507111]

Moist Heat or Steam Sterilization

[00840124507111]

Moist Heat or Steam Sterilization

[00840124507111]

Moist Heat or Steam Sterilization

[00840124507111]

Moist Heat or Steam Sterilization

[00840124507111]

Moist Heat or Steam Sterilization

[00840124507111]

Moist Heat or Steam Sterilization

[00840124507111]

Moist Heat or Steam Sterilization

[00840124507111]

Moist Heat or Steam Sterilization

[00840124507111]

Moist Heat or Steam Sterilization

[00840124507111]

Moist Heat or Steam Sterilization

[00840124507111]

Moist Heat or Steam Sterilization

[00840124507111]

Moist Heat or Steam Sterilization

[00840124507111]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-27
• Device Publish Date: 2022-10-19

On-Brand Devices [PolyLock SmallBone]

• 00840124507142: T-Plate Revision Compression 8 Hole
• 00840124507135: T-Plate Revision Compression 7 Hole
• 00840124507128: T-Plate Revision Compression 6 Hole
• 00840124507111: T-Plate Revision Compression 5 Hole
• 00840124507579: Tailors Bunion Plate Guide Lag Turret
• 00840124507562: Tailors Bunion Plate Guide Turret
• 00840124507555: Tailors Bunion Plate Guide Handle
• 00840124507548: Tailors Bunion Plate
• 00840124507623: Tailors Bunion Plate K-wire Guide
• 00840124507616: Tailors Bunion Plate Guide
• 00840124507609: Tailors Bunion Plate Reamer
• 00840124507593: Tailors Bunion Plate Lag Drill
• 00840124507586: Tailors Bunion Plate Distal Drill