DAN KERRISON RONGEURS, MODELS K1 + BILLY 1

• K Number: K023868
• Device Name: DAN KERRISON RONGEURS, MODELS K1 + BILLY 1
• Manufacturer: DANNORITZER MEDICAL INSTRUMENTS
• Date Cleared: 2003-02-07 ( 79 days)
• Product Code: HAE
• Regulation Number: 882.4840
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

DANNORITZER manual rongeurs are designed for cutting or biting bone during surgery involving the skull or spinal column.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement. The document is a clearance letter from the FDA for a medical device (Dan Kerrison Rongeurs), stating that it is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and marketing permissions but does not delve into specific performance studies or acceptance criteria.

Regulation Number and Section

§ 882.4840 Manual rongeur.

(a)
Identification. A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.(b)
Classification. Class II (performance standards).