Syntec Osteo-plate and screw Fixation

GUDID 04712782854400

Cortex Screw Self-Tappingφ3.5 x L75mm

SYNTEC SCIENTIFIC CORPORATION

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 04712782854400
• NIH Device Record Key: 206609ba-fd65-4083-98df-2d349635f8c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Syntec Osteo-plate and screw Fixation
• Version Model Number: 204875
• Company DUNS: 657692971
• Company Name: SYNTEC SCIENTIFIC CORPORATION
• 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: true
• 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	04712782854400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092889

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[04712782854400]

Moist Heat or Steam Sterilization

[04712782854400]

Moist Heat or Steam Sterilization

[04712782854400]

Moist Heat or Steam Sterilization

[04712782854400]

Moist Heat or Steam Sterilization

[04712782854400]

Moist Heat or Steam Sterilization

[04712782854400]

Moist Heat or Steam Sterilization

[04712782854400]

Moist Heat or Steam Sterilization

[04712782854400]

Moist Heat or Steam Sterilization

[04712782854400]

Moist Heat or Steam Sterilization

[04712782854400]

Moist Heat or Steam Sterilization

[04712782854400]

Moist Heat or Steam Sterilization

[04712782854400]

Moist Heat or Steam Sterilization

[04712782854400]

Moist Heat or Steam Sterilization

[04712782854400]

Moist Heat or Steam Sterilization

[04712782854400]

Moist Heat or Steam Sterilization

[04712782854400]

Moist Heat or Steam Sterilization

[04712782854400]

Moist Heat or Steam Sterilization

[04712782854400]

Moist Heat or Steam Sterilization

[04712782854400]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-26
• Device Publish Date: 2023-06-16

On-Brand Devices [Syntec Osteo-plate and screw Fixation]

• 04712782854349: Cortex Screw Self-Tappingφ3.5 x L45mm
• 04712782854332: Cortex Screw Self-Tappingφ3.5 x L40mm
• 04712782854318: Cortex Screw Self-Tappingφ3.5 x L36mm
• 04712782854295: Cortex Screw Self-Tappingφ3.5 x L32mm
• 04712782854479: Cortex Screw Self-Tappingφ3.5 x L110mm
• 04712782854462: Cortex Screw Self-Tappingφ3.5 x L105mm
• 04712782854455: Cortex Screw Self-Tappingφ3.5 x L100mm
• 04712782854448: Cortex Screw Self-Tappingφ3.5 x L95mm
• 04712782854431: Cortex Screw Self-Tappingφ3.5 x L90mm
• 04712782854424: Cortex Screw Self-Tappingφ3.5 x L85mm
• 04712782854417: Cortex Screw Self-Tappingφ3.5 x L80mm
• 04712782854400: Cortex Screw Self-Tappingφ3.5 x L75mm
• 04712782854394: Cortex Screw Self-Tappingφ3.5 x L70mm
• 04712782854387: Cortex Screw Self-Tappingφ3.5 x L65mm
• 04712782854370: Cortex Screw Self-Tappingφ3.5 x L60mm
• 04712782854325: Cortex Screw Self-Tappingφ3.5 x L38mm
• 04712782854301: Cortex Screw Self-Tappingφ3.5 x L34mm
• 04712782854288: Cortex Screw Self-Tappingφ3.5 x L30mm
• 04712782854264: Cortex Screw Self-Tappingφ3.5 x L26mm
• 04712782854240: Cortex Screw Self-Tappingφ3.5 x L22mm
• 04712782854226: Cortex Screw Self-Tappingφ3.5 x L18mm
• 04712782854219: Cortex Screw Self-Tappingφ3.5 x L16mm
• 04712782854202: Cortex Screw Self-Tappingφ3.5 x L14mm
• 04712782854196: Cortex Screw Self-Tappingφ3.5 x L12mm
• 04712782854189: Cortex Screw Self-Tappingφ3.5 x L10mm
• 04712782853991: Cortex Screw Self-Tappingφ2.7 x L40mm
• 04712782853984: Cortex Screw Self-Tappingφ2.7 x L38mm
• 04712782853977: Cortex Screw Self-Tappingφ2.7 x L36mm
• 04712782853960: Cortex Screw Self-Tappingφ2.7 x L34mm
• 04712782853953: Cortex Screw Self-Tappingφ2.7 x L32mm
• 04712782853946: Cortex Screw Self-Tappingφ2.7 x L30mm
• 04712782853939: Cortex Screw Self-Tappingφ2.7 x L28mm
• 04712782853922: Cortex Screw Self-Tappingφ2.7 x L26mm
• 04712782853915: Cortex Screw Self-Tappingφ2.7 x L24mm
• 04712782853908: Cortex Screw Self-Tappingφ2.7 x L22mm
• 04712782853892: Cortex Screw Self-Tappingφ2.7 x L20mm
• 04712782853885: Cortex Screw Self-Tappingφ2.7 x L18mm
• 04712782853878: Cortex Screw Self-Tappingφ2.7 x L16mm
• 04712782853861: Cortex Screw Self-Tappingφ2.7 x L14mm
• 04712782853854: Cortex Screw Self-Tappingφ2.7 x L12mm
• 04712782853847: Cortex Screw Self-Tappingφ2.7 x L10mm
• 04712782853830: Cortex Screw Self-Tappingφ2.7 x L8mm
• 04712782853823: Cortex Screw Self-Tappingφ2.7 x L6mm
• 04712782854363: Cortex Screw Self-Tappingφ3.5 x L55mm
• 04712782854356: Cortex Screw Self-Tappingφ3.5 x L50mm
• 04712782854271: Cortex Screw Self-Tappingφ3.5 x L28mm
• 04712782854257: Cortex Screw Self-Tappingφ3.5 x L24mm
• 04712782854233: Cortex Screw Self-Tappingφ3.5 x L20mm