INNOVERSE Spinal System

GUDID 08800037587275

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

• Primary Device ID: 08800037587275
• NIH Device Record Key: a9c91532-68fa-4d9e-9202-19fe4c4dd947
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INNOVERSE Spinal System
• Version Model Number: NP7035MSD
• 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: 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	08800037587275 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233960

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[08800037587275]

Moist Heat or Steam Sterilization

[08800037587275]

Moist Heat or Steam Sterilization

[08800037587275]

Moist Heat or Steam Sterilization

[08800037587275]

Moist Heat or Steam Sterilization

[08800037587275]

Moist Heat or Steam Sterilization

[08800037587275]

Moist Heat or Steam Sterilization

[08800037587275]

Moist Heat or Steam Sterilization

[08800037587275]

Moist Heat or Steam Sterilization

[08800037587275]

Moist Heat or Steam Sterilization

[08800037587275]

Moist Heat or Steam Sterilization

[08800037587275]

Moist Heat or Steam Sterilization

[08800037587275]

Moist Heat or Steam Sterilization

[08800037587275]

Moist Heat or Steam Sterilization

[08800037587275]

Moist Heat or Steam Sterilization

[08800037587275]

Moist Heat or Steam Sterilization

[08800037587275]

Moist Heat or Steam Sterilization

[08800037587275]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-26
• Device Publish Date: 2024-02-18

On-Brand Devices [INNOVERSE Spinal System]

• 08800247354735: NP60600C-H
• 08800247354728: NP60480C-H
• 08800247354711: NP60400C-H
• 08800247354704: NP60300C-H
• 08800247354698: NP60200C-H
• 08800247354681: NP60600T-H
• 08800247354674: NP60480T-H
• 08800247354667: NP60400T-H
• 08800247354650: NP60300T-H
• 08800247354643: NP60200T-H
• 08800247354636: NP55600C-H
• 08800247354629: NP55480C-H
• 08800247354612: NP55400C-H
• 08800247354605: NP55300C-H
• 08800247354599: NP55200C-H
• 08800247354582: NP55600T-H
• 08800247354575: NP55480T-H
• 08800247354568: NP55400T-H
• 08800247354551: NP55300T-H
• 08800247354544: NP55200T-H
• 08800247354537: NP60140C-M
• 08800247354520: NP60130C-M
• 08800247354513: NP60120C-M
• 08800247354506: NP60115C-M
• 08800247354490: NP60110C-M
• 08800247354483: NP60105C-M
• 08800247354476: NP60100C-M
• 08800247354469: NP60095C-M
• 08800247354452: NP60090C-M
• 08800247354445: NP60085C-M
• 08800247354438: NP60080C-M
• 08800247354421: NP60075C-M
• 08800247354414: NP60070C-M
• 08800247354407: NP60065C-M
• 08800247354391: NP60060C-M
• 08800247354384: NP60055C-M
• 08800247354377: NP60050C-M
• 08800247354360: NP60045C-M
• 08800247354353: NP60040C-M
• 08800247354346: NP60035C-M
• 08800247354339: NP60140T-M
• 08800247354322: NP60130T-M
• 08800247354315: NP60120T-M
• 08800247354308: NP60115T-M
• 08800247354292: NP60110T-M
• 08800247354285: NP60105T-M
• 08800247354278: NP60100T-M
• 08800247354261: NP60095T-M
• 08800247354254: NP60090T-M
• 08800247354247: NP60085T-M