AccessGUDID - DEVICE: THP™ Hip Fracture Plating System (00887868166242)

GUDID

Device Identifier (DI) Information

Brand Name: THP™ Hip Fracture Plating System
Version or Model: 14-451564
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 14-451564
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00887868166242
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 129278169 *Terms of Use

Device Description: No description.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
47562	Bone tap, single-use, non-sterile	A non-sterile, metal, surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a single-use device intended to be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KTT	APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
HWC	Screw, fixation, bone
JDO	DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173826	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
Device Size Text, specify: 5.0 mm

Device Record Status

Public Device Record Key: 05511500-b1c9-4fc8-8819-eda2f7f3cb5f
Public Version Date: May 30, 2025
Public Version Number: 3
DI Record Publish Date: March 27, 2019