AccessGUDID - DEVICE: CAPTURE™ High Torque Screw System (10381780122210)

GUDID

Device Identifier (DI) Information

Brand Name: CAPTURE™ High Torque Screw System
Version or Model: CSS50000017055T
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CSS50000017055T
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780122210
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
56642	Orthopaedic bone screw, non-bioabsorbable, non-sterile	A small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, fixation, bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092440	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 2.165 in L x .276 in dia; .72 in thread

Device Record Status

Public Device Record Key: ddb60c4f-149e-4c52-96a8-2b5e948598b4
Public Version Date: February 19, 2024
Public Version Number: 5
DI Record Publish Date: October 09, 2017