SECULOK™ Suture Anchor

GUDID 08800015996846

Innosys Co., Ltd.

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: 08800015996846
• NIH Device Record Key: 55967373-a619-4a57-b0b6-f9685dca5d64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SECULOK™ Suture Anchor
• Version Model Number: SFTA1410
• Company DUNS: 688811082
• Company Name: Innosys Co., Ltd.
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800015996846 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132101

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[08800015996846]

Ethylene Oxide

[08800015996846]

Ethylene Oxide

[08800015996846]

Ethylene Oxide

[08800015996846]

Ethylene Oxide

[08800015996846]

Ethylene Oxide

[08800015996846]

Ethylene Oxide

[08800015996846]

Ethylene Oxide

[08800015996846]

Ethylene Oxide

[08800015996846]

Ethylene Oxide

[08800015996846]

Ethylene Oxide

[08800015996846]

Ethylene Oxide

[08800015996846]

Ethylene Oxide

[08800015996846]

Ethylene Oxide

[08800015996846]

Ethylene Oxide

[08800015996846]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-06-19
• Device Publish Date: 2018-11-12

On-Brand Devices [SECULOK™ Suture Anchor]

• 08800037500137: PAS4500
• 08800037500120: PAS6503
• 08800037500113: PAS6502
• 08800037500106: PAS6501
• 08800037500090: PAS6500
• 08800037500083: PAS5503
• 08800037500076: PAS5502
• 08800037500069: PAS5501
• 08800037500052: PAS5500
• 08800037500045: PAS4503
• 08800037500038: PAS4502
• 08800037500021: PAS4501
• 08800015996846: SFTA1410