Crank Frame Retractor

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

510(k) Number

K882071 ↗

FDA Product Code

GZT

Device Class

Class II

Regulation

21 CFR Part 882.4800

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Suction Retractors

  Class I

  FDA 510(k) K882074 Active Cleared 16 Jun 1988

• Spinal Distractors, Spanners

  Class I

  FDA 510(k) K882069 Active Cleared 17 Jun 1988

• Cobb Spinal Elevators

  Class II

  FDA 510(k) K882068 Active Cleared 3 Jun 1988

• Lumbar Impaction Set and Bone Graft Impactors

  Class II

  FDA 510(k) K882070 Active Cleared 3 Jun 1988

• Self-Retaining Soft Tissue Retractor

  Class I

  FDA 510(k) K882075 Active Cleared 16 Jun 1988

• Suction Retractor(Tower Attach.)for Crank Fram Ret

  Class I

  FDA 510(k) K903969 Active Cleared 5 Sep 1990

See all devices from Karlin Technology, Inc. →

• What is the Crank Frame Retractor used for?

  The Crank Frame Retractor is designed specifically for neurosurgical procedures to provide controlled exposure of the spine. Its crank mechanism allows surgeons to maintain stable retraction, ensuring consistent access during delicate spinal operations where precision is critical.

• Is the Crank Frame Retractor reusable or single-use?

  The Crank Frame Retractor is supplied as a reusable device. This design choice supports cost efficiency and sustainability while maintaining the high standards required for sterile neurosurgical environments.

• How is the sterility of the Crank Frame Retractor ensured?

  The device is intended for use in sterile environments, such as operating rooms, where proper sterilization protocols must be followed. While the manufacturer does not specify sterilization methods in the provided data, reusable medical devices like this typically undergo rigorous cleaning and sterilization processes (e.g., autoclaving or chemical sterilization) between uses to ensure safety and compliance with medical standards.

• What regulatory approval does the Crank Frame Retractor hold?

  The Crank Frame Retractor holds FDA 510(k) clearance under the reference number K882071. This clearance confirms that the device meets FDA requirements for safety and effectiveness as a Class II medical device, specifically for use as a self-retaining retractor in neurosurgery.

• Are there different sizes or models of the Crank Frame Retractor?

  The provided data does not specify distinct sizes or model variations for the Crank Frame Retractor. However, retractors like this often come in multiple sizes to accommodate different patient anatomies or surgical needs. For precise sizing information, consulting the manufacturer’s technical documentation or contacting Karlin Technology directly would be recommended.