ACAB55105

GUDID 00841379131656

ROD, STRAIGHT

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 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 Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00841379131656
• NIH Device Record Key: c85fcbcc-6469-4c62-b2c1-bf8acb8da2cb
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: ACAB55105
• Catalog Number: ACAB55105
• 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
• 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
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM

Device Dimensions

• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841379131656 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153446

FDA Product Code

• OSH: Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Sterilization

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

[00841379131656]

Moist Heat or Steam Sterilization

[00841379131656]

Moist Heat or Steam Sterilization

[00841379131656]

Moist Heat or Steam Sterilization

[00841379131656]

Moist Heat or Steam Sterilization

[00841379131656]

Moist Heat or Steam Sterilization

[00841379131656]

Moist Heat or Steam Sterilization

[00841379131656]

Moist Heat or Steam Sterilization

[00841379131656]

Moist Heat or Steam Sterilization

[00841379131656]

Moist Heat or Steam Sterilization

[00841379131656]

Moist Heat or Steam Sterilization

[00841379131656]

Moist Heat or Steam Sterilization

[00841379131656]

Moist Heat or Steam Sterilization

[00841379131656]

Moist Heat or Steam Sterilization

[00841379131656]

Moist Heat or Steam Sterilization

[00841379131656]

Moist Heat or Steam Sterilization

[00841379131656]

Moist Heat or Steam Sterilization

[00841379131656]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-25

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• 00840085254420 - NA: 2024-05-07 POLYAXIAL, HIGH TOP, TULIP
• 00840085254437 - NA: 2024-05-07 POLYAXIAL, EXTENDED TAB, TULIP
• 00840085254444 - NA: 2024-05-07 FAVORED ANGLE M/L, TULIP
• 00840085254451 - NA: 2024-05-07 FAVORED ANGLE M/L, HIGH TOP, TULIP
• 00840085254468 - NA: 2024-05-07 FAVORED ANGLE M/L, EXTENED TAB, TULIP
• 00840085254475 - NA: 2024-05-07 FAVORED ANGLE C/C, TULIP
• 00840085254482 - NA: 2024-05-07 FAVORED ANGLE C/C, HIGH TOP, TULIP