C-JAWS Cervical Compressive Mini Frame

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

510(k) Number

K062181 ↗

FDA Product Code

KWP

Device Class

Class II

Regulation

21 CFR Part 888.3050

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Pass 2 Spinal System

  Class II

  FDA 510(k) K082069 Active Cleared 3 Oct 2008

• Modification to Passmed Spinal System

  Class II

  FDA 510(k) K070530 Active Cleared 18 Oct 2007

• C-Jaws Cervical Compressive Mini Frame

  Class II

  FDA 510(k) K072040 Active Cleared 3 Aug 2007

• Pass Anterior Spinal System

  Class II

  FDA 510(k) K102406 Active Cleared 23 Aug 2011

• Impix Lumbar Interbody Device Open recall

  Class II

  FDA 510(k) K100544 Active Cleared 22 Jul 2010

• Impix Spacer

  Class II

  FDA 510(k) K072226 Active Cleared 10 Dec 2007

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• What is the primary purpose of the C-JAWS Cervical Compressive Mini Frame in spinal surgery?

  The C-JAWS Cervical Compressive Mini Frame is designed to provide compressive support during cervical fusion procedures, helping to maintain the relative position of weak bony tissue. Unlike load-bearing implants, it works alongside allograft or autograft materials to stabilize the spine without bearing weight directly.

• Is this device meant for repeated use in the operating room, or is it single-use?

  The C-JAWS Cervical Compressive Mini Frame is intended for single-use in the operating room. It is supplied as part of a dedicated surgical instrument tray, meaning it should not be reused after a single surgical procedure.

• How should the C-JAWS Cervical Compressive Mini Frame be prepared for use, given it isn’t pre-sterilized?

  Since the device is not sterilized by the manufacturer, it must be processed according to standard surgical instrument protocols before use. This typically involves cleaning, sterilization (e.g., autoclave or ethylene oxide), and inspection to ensure safety and sterility before surgery.

• What types of surgical trays does this device come in, and is it sold separately?

  The C-JAWS Cervical Compressive Mini Frame is supplied as part of a dedicated surgical instrument tray, meaning it is not sold individually. The tray is specifically designed for use with this device during cervical spine procedures.

• What regulatory pathway was followed for FDA clearance of this device, and which advisory committee was involved?

  The C-JAWS Cervical Compressive Mini Frame received FDA 510(k) clearance (K062181) through the Traditional review pathway. The submission was reviewed by the Orthopedic (OR) Advisory Committee, which provides expert guidance on orthopedic devices like this one.