Product Code: OUR


Products Classified as OUR

4670Sacroiliac Joint FixationSmooth Or Threaded Metallic Bone Fixation Fastener.

Total Product Life Cycle (TPLC) Devices

4670Sacroiliac Joint FixationSmooth 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

K222605IFuse TORQ® Implant SystemSI-BONE, Inc.
K222448UNITY Sacroiliac Joint Fixation SystemDio Medical Corporation
K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate SystemAegis Spine, Inc.
K220195IFuse Bedrock Graniteâ„¢ Implant SystemSI-BONE, Inc.
K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC
K213667IFuse-TORQ® Implant SystemSI-BONE, Inc.
K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.
K211496TransLoc 3DFoundation Fusion Solutions, LLC (dba CornerLoc)
K210667FIREBIRD SI Fusion SystemOrthofix Inc.
K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.
K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate SystemAegis Spine
K203671M.U.S.T. Sacral Iliac Screw And Pelvic Trauma SystemMedacta International SA
K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC
K203373Advanced Research Medical Trident SI Screw SystemAdvanced Research Medical, LLC
K203247IFuse-TORQâ„¢ Implant SystemSI-BONE, Inc.

Global Unique Device Identification Database

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

Maude Adverse Events

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

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