Polarfix™ Facet Screw System

GUDID 08800015994675

Innosys Co., Ltd.

Surgical countersink, single-use Surgical countersink, single-use Surgical countersink, single-use Surgical countersink, single-use Surgical countersink, single-use Surgical countersink, single-use Surgical countersink, single-use Surgical countersink, single-use Surgical countersink, single-use Surgical countersink, single-use Surgical countersink, single-use Surgical countersink, single-use Surgical countersink, single-use Surgical countersink, single-use Surgical countersink, single-use

• Primary Device ID: 08800015994675
• NIH Device Record Key: 006754f8-63da-4841-b950-ca69531b8e5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polarfix™ Facet Screw System
• Version Model Number: FSA4525
• 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	08800015994675 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173198

FDA Product Code

• MRW: SYSTEM, FACET SCREW SPINAL DEVICE

Sterilization

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

[08800015994675]

Moist Heat or Steam Sterilization

[08800015994675]

Moist Heat or Steam Sterilization

[08800015994675]

Moist Heat or Steam Sterilization

[08800015994675]

Moist Heat or Steam Sterilization

[08800015994675]

Moist Heat or Steam Sterilization

[08800015994675]

Moist Heat or Steam Sterilization

[08800015994675]

Moist Heat or Steam Sterilization

[08800015994675]

Moist Heat or Steam Sterilization

[08800015994675]

Moist Heat or Steam Sterilization

[08800015994675]

Moist Heat or Steam Sterilization

[08800015994675]

Moist Heat or Steam Sterilization

[08800015994675]

Moist Heat or Steam Sterilization

[08800015994675]

Moist Heat or Steam Sterilization

[08800015994675]

Moist Heat or Steam Sterilization

[08800015994675]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-06-19
• Device Publish Date: 2018-05-17

On-Brand Devices [Polarfix™ Facet Screw System]

• 08800037500250: FSA5550N
• 08800037500243: FSA5545N
• 08800037500236: FSA5540N
• 08800037500229: FSA5535N
• 08800037500212: FSA5530N
• 08800037500205: FSA5525N
• 08800037500199: FSA4550N
• 08800037500182: FSA4545N
• 08800037500175: FSA4540N
• 08800037500168: FSA4535N
• 08800037500151: FSA4530N
• 08800037500144: FSA4525N
• 08800015994866: FS0080
• 08800015994859: FS0070
• 08800015994842: FS0060
• 08800015994835: FS0050
• 08800015994828: FS0040
• 08800015994811: FS0030
• 08800015994804: FS0020
• 08800015994798: FS0010
• 08800015994781: FSA5550
• 08800015994774: FSA5545
• 08800015994767: FSA5540
• 08800015994750: FSA5535
• 08800015994743: FSA5530
• 08800015994736: FSA5525
• 08800015994729: FSA4550
• 08800015994712: FSA4545
• 08800015994705: FSA4540
• 08800015994699: FSA4535
• 08800015994682: FSA4530
• 08800015994675: FSA4525
• 08800037586186: FS0050
• 08800037586179: FS0040
• 08800037586162: FS0010