Pisces-SA 1790-0007

GUDID B06217900007

20° Trial Module, PISCES™-SA

Osseus Fusion Systems, LLC

Orthopaedic implant/instrument depth limiter Orthopaedic implant/instrument depth limiter Orthopaedic implant/instrument depth limiter Orthopaedic implant/instrument depth limiter Orthopaedic implant/instrument depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter

• Primary Device ID: B06217900007
• NIH Device Record Key: 3b380582-4629-4e67-9319-5b6e8944256d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pisces-SA
• Version Model Number: 1790-0007
• Catalog Number: 1790-0007
• Company DUNS: 933442068
• Company Name: Osseus Fusion Systems, LLC
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B06217900007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213935

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

[B06217900007]

Moist Heat or Steam Sterilization

[B06217900007]

Moist Heat or Steam Sterilization

[B06217900007]

Moist Heat or Steam Sterilization

[B06217900007]

Moist Heat or Steam Sterilization

[B06217900007]

Moist Heat or Steam Sterilization

[B06217900007]

Moist Heat or Steam Sterilization

[B06217900007]

Moist Heat or Steam Sterilization

[B06217900007]

Moist Heat or Steam Sterilization

[B06217900007]

Moist Heat or Steam Sterilization

[B06217900007]

Moist Heat or Steam Sterilization

[B06217900007]

Moist Heat or Steam Sterilization

[B06217900007]

Moist Heat or Steam Sterilization

[B06217900007]

Moist Heat or Steam Sterilization

[B06217900007]

Moist Heat or Steam Sterilization

[B06217900007]

Moist Heat or Steam Sterilization

[B06217900007]

Moist Heat or Steam Sterilization

[B06217900007]

Moist Heat or Steam Sterilization

[B06217900007]

Moist Heat or Steam Sterilization

[B06217900007]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-26
• Device Publish Date: 2022-05-18

On-Brand Devices [Pisces-SA]

• B06217900007: 20° Trial Module, PISCES™-SA
• B06217900006: 16° Trial Module, PISCES™-SA
• B06217900005: 12° Trial Module, PISCES™-SA
• B0621752L170: 29x39x17, 20°, Trial, PISCES-SA
• B0621750S198: 23x29x19, 8°, Trial, PISCES-SA
• B0621750S196: 23x29x19, 16°, Trial, PISCES-SA
• B0621750S192: 23x29x19, 12°, Trial, PISCES-SA
• B0621750S190: 23x29x19, 20°, Trial, PISCES-SA
• B0621750S178: 23x29x17, 8°, Trial, PISCES-SA
• B0621750S176: 23x29x17, 16°, Trial, PISCES-SA
• B0621750S172: 23x29x17, 12°, Trial, PISCES-SA
• B0621750S170: 23x29x17, 20°, Trial, PISCES-SA
• B0621750S158: 23x29x15, 8°, Trial, PISCES-SA
• B0621750S156: 23x29x15, 16°, Trial, PISCES-SA
• B0621750S152: 23x29x15, 12°, Trial, PISCES-SA
• B0621750S150: 23x29x15, 20°, Trial, PISCES-SA
• B0621750S138: 23x29x13, 8°, Trial, PISCES-SA
• B0621750S136: 23x29x13, 16°, Trial, PISCES-SA
• B0621750S132: 23x29x13, 12°, Trial, PISCES-SA
• B0621750S130: 23x29x13, 20°, Trial, PISCES-SA
• B0621750S118: 23x29x11, 8°, Trial, PISCES-SA
• B0621750S116: 23x29x11, 16°, Trial, PISCES-SA
• B0621750S112: 23x29x11, 12°, Trial, PISCES-SA
• B0621750S110: 23x29x11, 20°, Trial, PISCES-SA
• B0621750S098: 23x29x09, 8°, Trial, PISCES-SA
• B0621750S096: 23x29x09, 16°, Trial, PISCES-SA
• B0621750S092: 23x29x09, 12°, Trial, PISCES-SA
• B0621750S078: 23x29x07, 8°, Trial, PISCES-SA
• B0621750S076: 23x29x07, 16°, Trial, PISCES-SA
• B0621750S072: 23x29x07, 12°, Trial, PISCES-SA
• B0621750M198: 26x35x19, 8°, Trial, PISCES-SA
• B0621750M196: 26x35x19, 16°, Trial, PISCES-SA
• B0621750M192: 26x35x19, 12°, Trial, PISCES-SA
• B0621750M190: 26x35x19, 20°, Trial, PISCES-SA
• B0621750M178: 26x35x17, 8°, Trial, PISCES-SA
• B0621750M176: 26x35x17, 16°, Trial, PISCES-SA
• B0621750M172: 26x35x17, 12°, Trial, PISCES-SA
• B0621750M170: 26x35x17, 20°, Trial, PISCES-SA
• B0621750M158: 26x35x15, 8°, Trial, PISCES-SA
• B0621750M156: 26x35x15, 16°, Trial, PISCES-SA
• B0621750M152: 26x35x15, 12°, Trial, PISCES-SA
• B0621750M150: 26x35x15, 20°, Trial, PISCES-SA
• B0621750M138: 26x35x13, 8°, Trial, PISCES-SA
• B0621750M136: 26x35x13, 16°, Trial, PISCES-SA
• B0621750M132: 26x35x13, 12°, Trial, PISCES-SA
• B0621750M130: 26x35x13, 20°, Trial, PISCES-SA
• B0621750M118: 26x35x11, 8°, Trial, PISCES-SA
• B0621750M116: 26x35x11, 16°, Trial, PISCES-SA
• B0621750M112: 26x35x11, 12°, Trial, PISCES-SA
• B0621750M110: 26x35x11, 20°, Trial, PISCES-SA