FEDA04040

GUDID 00841379154433

OFFSET ROD CONNECTOR, CLOSED

HYHTE HOLDINGS, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00841379154433
• NIH Device Record Key: 43a109d4-a7c7-4532-bc7d-1ac1aa32f152
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: FEDA04040
• Catalog Number: FEDA04040
• Company DUNS: 073029645
• Company Name: HYHTE HOLDINGS, 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: 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

Customer Support Contacts

• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM

Device Dimensions

• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 4 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 4 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 4 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 4 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 4 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 4 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 4 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841379154433 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171250

FDA Product Code

• NKG: Posterior Cervical Screw System

Sterilization

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

[00841379154433]

Moist Heat or Steam Sterilization

[00841379154433]

Moist Heat or Steam Sterilization

[00841379154433]

Moist Heat or Steam Sterilization

[00841379154433]

Moist Heat or Steam Sterilization

[00841379154433]

Moist Heat or Steam Sterilization

[00841379154433]

Moist Heat or Steam Sterilization

[00841379154433]

Moist Heat or Steam Sterilization

[00841379154433]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-02
• Device Publish Date: 2021-07-23

Devices Manufactured by HYHTE HOLDINGS, INC.

• 00840085265488 - NA: 2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265495 - NA: 2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265501 - NA: 2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265518 - NA: 2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265525 - NA: 2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265532 - NA: 2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265549 - NA: 2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265556 - NA: 2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW