Pisces-SA 1760-7094

GUDID B06217607094

Paddle Distractor, 13mm

Osseus Fusion Systems, LLC

Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal

• Primary Device ID: B06217607094
• NIH Device Record Key: 11f697f2-ff85-4b62-87a0-f67c323cf8c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pisces-SA
• Version Model Number: 1760-7094
• Catalog Number: 1760-7094
• 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	B06217607094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213935

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[B06217607094]

Moist Heat or Steam Sterilization

[B06217607094]

Moist Heat or Steam Sterilization

[B06217607094]

Moist Heat or Steam Sterilization

[B06217607094]

Moist Heat or Steam Sterilization

[B06217607094]

Moist Heat or Steam Sterilization

[B06217607094]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-31
• Device Publish Date: 2022-05-23

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