Songer Cable System

510(k) Number

K941213 ↗

FDA product code

JDQ

Device class

Class II

Regulation

21 CFR Part 888.3010

Advisory committee

Orthopedic

FDA decision

SN

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code JDQ (Cerclage, Fixation).

• PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF) by Pectofix, Inc.
• SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM by Synthes (Usa)
• Arthrex® AR-9953CB-T45 by Arthrex, Inc.
• SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS by Sic Brevetti S.R.L.
• Frontier Medical Devices In-line Orthopedic Cable Cerclage System by Frontier Medical Devices, Inc.
• Cable-Ready® 2232-50-19 by Zimmer, Inc.
• ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER) by Kinamed, Incorporated
• DEPUY (NITINO) GUIDE WIRE by Depuy, Inc.
• DALL-MILES TROCHANTER CABLE SUPERGRIP by Howmedica Corp.
• DSM Biomedical DPR Cable by DSM BIOMEDICAL, INC.

• Pacp

  Class II

  FDA 510(k) K083663 Active Cleared 25 Feb 2009

• Modification to: Pioneer Surgical Technology Quantum Spinal System

  Class II

  FDA 510(k) K070551 Active Cleared 29 Mar 2007

• Tritium Sternal Cable Plate System

  Class II

  FDA 510(k) K193468 Active Cleared 12 Mar 2020

• Pioneer Vertebral Spacer (Vertebral Spacer)

  Class II

  FDA 510(k) K061151 Active Cleared 24 Jul 2006

See all devices from Pioneer Surgical Technology, Inc. →