Product Code: OUR

Products Classified as OUR

4670

Sacroiliac Joint Fixation

Smooth Or Threaded Metallic Bone Fixation Fastener.

Total Product Life Cycle (TPLC) Devices

4670

Sacroiliac Joint Fixation

Smooth Or Threaded Metallic Bone Fixation Fastener.

FDA Consensus Standards

• Sacroiliac Joint Fixation [34059]: 21 CFR §888.3040 🔎
• Sacroiliac Joint Fixation [34070]: 21 CFR §888.3040 🔎

Pre-market Notifications for OUR

K222605	IFuse TORQ® Implant System	SI-BONE, Inc.
K222448	UNITY Sacroiliac Joint Fixation System	Dio Medical Corporation
K221050	ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System	Aegis Spine, Inc.
K220195	IFuse Bedrock Granite™ Implant System	SI-BONE, Inc.
K214123	T-FIX® 3DSI Joint Fusion System	Cutting Edge Spine, LLC
K213667	IFuse-TORQ® Implant System	SI-BONE, Inc.
K212903	SIMPACT Sacroiliac Joint Fixation System	Life Spine, Inc.
K211496	TransLoc 3D	Foundation Fusion Solutions, LLC (dba CornerLoc)
K210667	FIREBIRD SI Fusion System	Orthofix Inc.
K210402	Curiteva Sacroiliac Joint Fusion System	Curiteva, Inc.
K210035	ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System	Aegis Spine
K203671	M.U.S.T. Sacral Iliac Screw And Pelvic Trauma System	Medacta International SA
K203503	Camber Sacroiliac (SI) Fixation System	Camber Spine Technologies, LLC
K203373	Advanced Research Medical Trident SI Screw System	Advanced Research Medical, LLC
K203247	IFuse-TORQ™ Implant System	SI-BONE, Inc.

Global Unique Device Identification Database

• 00643169572577: Sacroiliac joint fixation
• 00643169572560: Sacroiliac joint fixation
• 00643169571860: Sacroiliac joint fixation
• 00643169571815: Sacroiliac joint fixation
• 00801741105012: Sacroiliac joint fixation
• 00190837020743: Sacroiliac Joint Fixation
• 00190837020736: Sacroiliac Joint Fixation
• 00190837020729: Sacroiliac Joint Fixation
• 00190837020712: Sacroiliac Joint Fixation
• 00190837020705: Sacroiliac Joint Fixation
• 00190837020699: Sacroiliac Joint Fixation
• 00190837020682: Sacroiliac Joint Fixation
• 00190837020675: Sacroiliac Joint Fixation
• 00190837020668: Sacroiliac Joint Fixation
• 00190837014247: Sacroiliac Joint Fixation

Maude Adverse Events

IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-03-31
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-03-31
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-03-30
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-03-30
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-03-30
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-03-30
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-03-30
SILEX SACROILIAC JOINT FUSION SYSTEM	X-SPINE SYSTEMS, INC.	2020-03-20
SILEX SACROILIAC JOINT FUSION SYSTEM	X-SPINE SYSTEMS, INC.	2020-03-19
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-03-18
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-03-17
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-03-10
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-03-05
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-03-05
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-03-03
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-03-03
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-02-27
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-02-27
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-02-26
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-02-26
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-02-25
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-02-25
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-02-25
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-02-25
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-02-24
CATAMARAN 10X40MM SIJ IMPLANT	TENON MEDICAL, INC.	2020-02-20
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-02-17
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-02-13
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-02-11
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-02-10
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-02-10
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-02-05
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-02-05
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-02-05
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-02-05
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-02-03
SILEX SACROILIAC JOINT FUSION SYSTEM	X-SPINE SYSTEMS, INC.	2020-01-24
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-01-13
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-01-07
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-01-07
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-01-07
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-01-06
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-01-02
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-01-02
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-01-02
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2020-01-02
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2019-11-26
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2019-11-26
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2019-11-26
IFUSE IMPLANT SYSTEM	SI-BONE, INC.	2019-11-26