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CAPTURE™ High Torque Screw System

FDA UDI

Class II (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name
CAPTURE™ High Torque Screw System FDA UDI
Generic Name
Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Device Name
Cannulated screw is a machined, metallic screw that is manufactured from stainless steel and titanium with a cannulation that is self-drilling and self-tapping. The CAPTURE High-Torque Screw is intended for fixation of the pelvis and illiosacral join, as well as fixations of fractures and osteotomies in long and small bones, including those in the foot, patella, ankle, wrist, and elbow. Intended for use correction Arthrodesis of the foot, wrist and elbow. FDA UDI
Model / Reference
CSS50000034044T FDA UDI
Description
Cannulated screw is a machined, metallic screw that is manufactured from stainless steel and titanium with a cannulation that is self-drilling and self-tapping. The CAPTURE High-Torque Screw is intended for fixation of the pelvis and illiosacral join, as well as fixations of fractures and osteotomies in long and small bones, including those in the foot, patella, ankle, wrist, and elbow. Intended for use correction Arthrodesis of the foot, wrist and elbow. FDA UDI

Identifiers

Catalog Number
CSS50000034044T FDA UDI
Primary DI / UDI-DI
10381780122654 FDA UDI
510(k) Number
K092440 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile

CAPTURE™ High Torque Screw System by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.

Cleared under the same submission

K092440 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ascension Orthopedics, Inc.

Sources (1)

  • FDA UDI 5dab0641-ba9c-46a1-91c0-7bf5ab0107f8 38 fields · synced May 30, 2026