PLS

GUDID 00810086193714

3LOCK- Dual-lead multiaxial cannulated fenestrated screw- l.55mm-ø8mm

SINTEA USA, LLC

Bone-screw internal spinal fixation system rod

• Primary Device ID: 00810086193714
• NIH Device Record Key: 8aaf2c2a-c887-49e9-a63b-b53496da553f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PLS
• Version Model Number: PLS-855T58
• Company DUNS: 079917057
• Company Name: SINTEA USA, LLC
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 3054906850
• Email: info@sinteausa.com
• Phone: 3054906850
• Email: info@sinteausa.com
• Phone: 3054906850
• Email: info@sinteausa.com
• Phone: 3054906850
• Email: info@sinteausa.com
• Phone: 3054906850
• Email: info@sinteausa.com
• Phone: 3054906850
• Email: info@sinteausa.com
• Phone: 3054906850
• Email: info@sinteausa.com
• Phone: 3054906850
• Email: info@sinteausa.com
• Phone: 3054906850
• Email: info@sinteausa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810086193714 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140787

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[00810086193714]

Moist Heat or Steam Sterilization

[00810086193714]

Moist Heat or Steam Sterilization

[00810086193714]

Moist Heat or Steam Sterilization

[00810086193714]

Moist Heat or Steam Sterilization

[00810086193714]

Moist Heat or Steam Sterilization

[00810086193714]

Moist Heat or Steam Sterilization

[00810086193714]

Moist Heat or Steam Sterilization

[00810086193714]

Moist Heat or Steam Sterilization

[00810086193714]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-12
• Device Publish Date: 2024-12-04

On-Brand Devices [PLS]

• 00810086190867: DUAL LEAD SCREW DIAMETER 5 MM - LENGTH 35 MM
• 00810086193714: 3LOCK- Dual-lead multiaxial cannulated fenestrated screw- l.55mm-ø8mm
• 00810086193691: 3LOCK- Dual-lead multiaxial cannulated fenestrated screw- l.45mm-ø8mm
• 00810086193554: 3LOCK- Dual-lead multiaxial cannulated fenestrated screw- l.50mm-ø7mm
• 00810086193547: 3LOCK- Dual-lead multiaxial cannulated fenestrated screw- l.45mm-ø7mm
• 00810086193400: 3LOCK- Dual-lead multiaxial cannulated fenestrated screw- l.50mm-ø6mm
• 00810086193394: 3LOCK- Dual-lead multiaxial cannulated fenestrated screw- l.45mm-ø6mm
• 00810086191161: Dual Lead Screw Ø7 L35mm
• 00810086191154: Dual Lead Screw Ø7 L30mm
• 00810086191055: Dual Lead Screw Ø6 L55mm
• 00810086191000: Dual Lead Screw Ø6 L30mm
• 00810086190898: Dual Lead Screw Ø5 L50mm
• 00810086190881: Dual Lead Screw Ø5 L45mm
• 00810086190874: Dual Lead Screw Ø5 L40mm
• 00810086190737: Dual Lead Screw ø4mm L45mm
• 00810086190713: Dual Lead Screw ø4mm L35mm
• 00810086190706: Dual Lead Screw ø4mm L30mm
• 00810086190720: Dual Lead Screw ø4mm L40mm