10x40mm SIJ Implant CAT-04

GUDID B74240295041

Implant

TENON MEDICAL, INC.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile

Primary Device ID	B74240295041
NIH Device Record Key	a58142ca-1d49-40cc-89e4-abaddd5fc91b
Commercial Distribution Status	In Commercial Distribution
Brand Name	10x40mm SIJ Implant
Version Model Number	CAT-04
Catalog Number	CAT-04
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	true
Manufacturing Date	false
Expiration Date	true
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	B74240295041 [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

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

[B74240295041]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-05-31
Device Publish Date	2019-05-23

Devices Manufactured by TENON MEDICAL, INC.

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00850033676419 - Catamaran® SE SIJ Fusion System	2025-04-03 Implant, CAT-01, 7.5mm X 40mm, Catamaran
00850033676426 - Catamaran® SE SIJ Fusion System	2025-04-03 LP Inserter, 7.5mm, Catamaran
00850033676433 - Catamaran® SE SIJ Fusion System	2025-04-03 LP Inserter Screw, 7.5mm, Catamaran
00850033676440 - Catamaran® SE SIJ Fusion System	2025-04-03 LP Access Sleeve, 7.5mm, Catamaran
00850033676457 - Catamaran® SE SIJ Fusion System	2025-04-03 LP Drill Guide, 7.5mm, Catamaran
00850033676471 - Catamaran® SIJ Fusion System	2025-04-03 LP Handle, Access Sleeve, Catamaran
00850033676495 - Catamaran® SIJ Fusion System	2025-04-03 Driver, K-Wire, 7.5mm, Catamaran

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