Isola Twister Connector

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K965046 ↗

FDA Product Code

MNH

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SN

• University Plate Anterior System

  Class II

  FDA 510(k) K980228 Active Cleared 14 Apr 1998

• Acromed Double Sublaminar Wire

  Class II

  FDA 510(k) K895413 Active Cleared 22 Nov 1989

• Isola(R) Tandem Connector

  Class II

  FDA 510(k) K922504 Active Cleared 18 May 1993

• Acromed Pedicle Screw

  Class II

  FDA 510(k) K951116 Active Cleared 11 Aug 1995

• Vsp (Variable Screw Placement) Spinal Fixation System, Pedicle Screw(S), Spine Plate(S), Washer(S) & Nut(S)

  Class II

  FDA 510(k) K951657 Active Cleared 21 Aug 1995

• Isola(Tm) Spine System--Eye Rod

  Class II

  FDA 510(k) K911394 Active Cleared 21 Jun 1991

See all devices from Acromed Corp. →

• What is the Isola Twister Connector used for?

  The Isola Twister Connector is an orthopedic device, substantially equivalent for some indications, but its specific use is not detailed in the provided data.

• How is the Isola Twister Connector supplied?

  The Isola Twister Connector is supplied by Acromed Corp, but details on packaging, sterility, or single-use status are not provided.

• What regulatory authorizations does the Isola Twister Connector have?

  The Isola Twister Connector has FDA 510K authorizations, with a specific k number, K965046, indicating its clearance status.