AccessGUDID - DEVICE: EpiFIX (B562PKEFC0212SSUS0)

GUDID

Device Identifier (DI) Information

Brand Name: EpiFIX
Version or Model: PK-EFC0212SS-US
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PK-EFC0212SS
Company Name: Wishbone Medical, Inc.

Primary DI Number: B562PKEFC0212SSUS0
Issuing Agency: HIBCC
Commercial Distribution End Date: December 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 062355158 *Terms of Use

Device Description: Procedure Kit, Curved 2-Hole X 12mm EpiFIX Plate, Instruments and Solid Screws, SS

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":	Yes
For Single-Use:	Yes
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?
44896	Growth-correction orthopaedic fixation plate kit	A collection of implantable devices used to redirect the angle of growth of long bones in paediatric patients where the growth plates (epiphysial cartilage) are not fused, to allow for the gradual correction of congenital or acquired deformities (e.g., valgus, varus, or flexion deformities of the knee, ankle, or elbow). It typically includes various-sized sheets of surgical steel or titanium alloy, and bone screws to attach the sheets to the bone surface over the growth plates. The screws may be allowed to swivel in their position so that the implant acts like a hinge, permitting growth at the growth plate to gradually straighten the limb.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OBT	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182704	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: 7de9cacd-6853-45b0-af07-f76c05751682
Public Version Date: February 19, 2024
Public Version Number: 5
DI Record Publish Date: March 15, 2021