CATAMARAN™ SIJ Fusion System 40350

GUDID 00850033676198

Extraction Screw, 10mm, Catamaran

TENON MEDICAL, INC.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile

• Primary Device ID: 00850033676198
• NIH Device Record Key: a66cb124-0c56-41c0-9191-752f65e50088
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CATAMARAN™ SIJ Fusion System
• Version Model Number: 40350
• Catalog Number: 40350
• Company DUNS: 117014636
• Company Name: TENON MEDICAL, INC.
• 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: true
• 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
GS1	00850033676198 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180818

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[00850033676198]

Moist Heat or Steam Sterilization

[00850033676198]

Moist Heat or Steam Sterilization

[00850033676198]

Moist Heat or Steam Sterilization

[00850033676198]

Moist Heat or Steam Sterilization

[00850033676198]

Moist Heat or Steam Sterilization

[00850033676198]

Moist Heat or Steam Sterilization

[00850033676198]

Moist Heat or Steam Sterilization

[00850033676198]

Moist Heat or Steam Sterilization

[00850033676198]

Moist Heat or Steam Sterilization

[00850033676198]

Moist Heat or Steam Sterilization

[00850033676198]

Moist Heat or Steam Sterilization

[00850033676198]

Moist Heat or Steam Sterilization

[00850033676198]

Moist Heat or Steam Sterilization

[00850033676198]

Moist Heat or Steam Sterilization

[00850033676198]

Moist Heat or Steam Sterilization

[00850033676198]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-27
• Device Publish Date: 2021-12-17

On-Brand Devices [CATAMARAN™ SIJ Fusion System]

• 00850033676273: CATAMARAN™ SIJ Fusion System
• 00850033676266: Lid, Sterilization Tray, Catamaran
• 00850033676259: Sterilization Tray, Catamaran
• 00850033676242: Drill Bit 10mmx60mm, Catamaran
• 00850033676235: Drill Bit 10mmx40mm, Catamaran
• 00850033676228: Flange, Slap Hammer, Catamaran
• 00850033676211: Rod, Slap Hammer, Catamaran
• 00850033676204: Slap Hammer, Catamaran
• 00850033676198: Extraction Screw, 10mm, Catamaran
• 00850033676181: Extraction Fork 10mm, Catamaran
• 00850033676174: Bone Pusher Rod 10mm, Catamaran
• 00850033676167: Bone Pusher Head 10mm, Catamaran
• 00850033676150: Funnel Cone 10mm, Catamaran
• 00850033676143: Funnel Tube 10mm, Catamaran
• 00850033676136: Hex Key 4mm, Catamaran
• 00850033676129: Inserter Screw 10mm, Catamaran
• 00850033676112: Inserter 10mm, Catamaran
• 00850033676105: Temporary Pin 10mm, Catamaran
• 00850033676099: Ball Tip Probe, Catamaran
• 00850033676082: Drill Bit 10mmx50mm, Catamaran
• 00850033676075: Drill Guide 10mm, Catamaran
• 00850033676068: Awl, 10mm, Catamaran
• 00850033676051: K-Wire, Catamaran
• 00850033676044: Graduated Guide Wire, Catamaran
• 00850033676037: Handle, Access Sleeve, Catamaran
• 00850033676020: Access Sleeve, Catamaran
• 00850033676013: Implant, CAT-04, 10mm x 40mm
• 00850033676006: Implant, CAT-03, 10mm x 30mm
• 00850033676303: Lid, Instrument Tray, Catamaran
• 00850033676297: Base, Instrument Tray, Catamaran
• 00850033676280: Drill Bit 10mmx70mm, Catamaran