KRD1 PEDICLE SCREW SYSTEM— 510(k) K092420

Clearance details

Applicant

Spinefrontier, Inc.

Product code

Code MNI

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2009-08-06

Decision date

2009-11-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Beverly, MA, US

• K171497 — Mikron Spinal Fixation System2017-10-12
• K160731 — LumFix Spinal Fixation Sytem2016-10-04
• K151458 — Double Medical Universal Spine System2016-08-22
• K153273 — MySpine Pedicle Screw Placement Guides - LP2016-06-29
• K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System2016-04-04

• K193106 — SpineFrontier Lumbar Interbody Fusion Device System2020-06-19
• K172484 — A-CIFT SoloFuse2018-05-08
• K151198 — A-CIFT SoloFuse2015-07-17
• K142504 — SpineFrontier Lumbar Interbody Fusion Device System2015-05-13
• K150017 — SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System2015-04-24

Injury

641

Total

641

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1926-2013 — Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds the screw in place. There is also a feature used to lock the screw to the inserter before insertion of the screw. They can also be used to remove screws or back screws out. Screw inserters are used during the implantation of spinal pedicle screws intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. Used in conjunction with Pedicle Screw Spinal system marketed as KRD1 PedFuse Pedicle Screw System .Class II·Terminated·SpineFrontier, Inc.·20130314
• Z-1737-2013 — KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be placed along several pedicle screws. Component rods are used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients.Class II·Terminated·SpineFrontier, Inc.·20111230

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092420.