AccessGUDID - DEVICE: HyProCure II Instrument Tray-Set (M621HYPIIINSTRAY0)

GUDID

Device Identifier (DI) Information

Brand Name: HyProCure II Instrument Tray-Set
Version or Model: HYPII-INS-TRAY
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HYPII-INS-TRAY
Company Name: Gramedica

Primary DI Number: M621HYPIIINSTRAY0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 828660345 *Terms of Use

Device Description: HyProCure II (reusable) Instrument Tray-Kit. The Instrument kit contains seven Trial Sizers (06mm thru 12mm) one Driver, one Positioning Sleeve and three Guide Wires). For use with the HyProCure II Sinus Tarsi Implants. Indications: The HyProCure II (HYP II and HYP IIs) Implant is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion

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?
13180	Orthopaedic prosthesis implantation positioning instrument, reusable	A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142534	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: 7e87822a-c9d3-4ed3-9196-df2c87934afe
Public Version Date: May 03, 2023
Public Version Number: 5
DI Record Publish Date: February 14, 2017