CAPTURE™ High Torque Screw System - The Capture High-Torque Screw System consists of - Ascension Orthopedics, Inc.

Duns Number:942377524

Device Description: The Capture High-Torque Screw System consists of various sizes of cannulated screws. The s The Capture High-Torque Screw System consists of various sizes of cannulated screws. The screws are machined, metallic screws with a cannulation that are self-drilling and self-tapping. Each type is offered in a variety of diameters and lengths and is manufactured from stainless steel and titanium. The system is intended for fixation of fractures in long bones, fixation of small bones, arthrodesis of the foot, wrist and elbow, and small and long bone osteotomies. This particular system consists of 4.0mm and 5.0mm screws. Instruments are provided to assist with the implants.

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More Product Details

Catalog Number

HITORQ45IMP

Brand Name

CAPTURE™ High Torque Screw System

Version/Model Number

HITORQ45IMP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K092440

Product Code Details

Product Code

HWC

Product Code Name

Screw, fixation, bone

Device Record Status

Public Device Record Key

11831413-dbb9-4868-8801-ade25add38d5

Public Version Date

July 16, 2020

Public Version Number

4

DI Record Publish Date

September 22, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ASCENSION ORTHOPEDICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1909
2 A medical device with a moderate to high risk that requires special controls. 1404
3 A medical device with high risk that requires premarket approval 12
U Unclassified 15