AccessGUDID - DEVICE: WishFIX (B562XKEFC0216S080)

GUDID

Device Identifier (DI) Information

Brand Name: WishFIX
Version or Model: XK-EFC0216S-08
Commercial Distribution Status: In Commercial Distribution
Catalog Number: XK-EFC0216S
Company Name: Wishbone Medical, Inc.

Primary DI Number: B562XKEFC0216S080
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 062355158 *Terms of Use

Device Description: "Express Kit, Curved 2-Hole X 16mm WishFIX Plate, Instruments and 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?
46647	Orthopaedic fixation plate, non-bioabsorbable	A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.	Active	true

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: 23065fd0-9ea4-4d1f-84c5-898f083c815e
Public Version Date: September 18, 2023
Public Version Number: 3
DI Record Publish Date: December 16, 2021