AccessGUDID - DEVICE: WishBone Plate & Screw System (B562PKTCX35SM0)

GUDID

Device Identifier (DI) Information

Brand Name: WishBone Plate & Screw System
Version or Model: PK-TCX35SM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PK-TCX35SM
Company Name: Wishbone Medical, Inc.

Primary DI Number: B562PKTCX35SM0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 062355158 *Terms of Use

Device Description: Procedure Kit- 3.5 mm Cortical Screws (10mm-16mm) and Instruments, Ti

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?
46649	Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial	A collection of small sheets of firm material and bone screws intended to be implanted onto fractured bone fragments to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals. The components are made of a material that is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre); it does not include an antimicrobial agent(s). Tools for implantation may be included. The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180736	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: 208a2512-801e-4c1f-ac5f-a96c15988f80
Public Version Date: February 19, 2024
Public Version Number: 4
DI Record Publish Date: December 02, 2020