AccessGUDID - DEVICE: Construct® Ankle Fusion Plate System (10381780064497)

GUDID

Device Identifier (DI) Information

Brand Name: Construct® Ankle Fusion Plate System
Version or Model: AFPIMP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AFPIMP
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780064497
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use

Device Description: The Construct Ankle Fusion Plate System consists of two anterior tibia-talus and a lateral tibia-talus-calcaneus arthrodesis plates. The plates are contoured to the peri articular anatomy and have tapered threaded holes which accept compression or locking threaded screws with a major thread diameter of 4.5 or 6.5mm. All plates and screws are manufactured from stainless steel or titanium. The system is intended for arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, fusions, and replantation of small bones in the foot and ankle. Instruments are provided.

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
61689	Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile	A non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, fixation, bone
HRS	PLATE, FIXATION, BONE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100176	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
No Device Sizes

Device Record Status

Public Device Record Key: aba859c0-6180-415a-bdb8-3f124d549902
Public Version Date: February 19, 2024
Public Version Number: 6
DI Record Publish Date: September 22, 2015