AccessGUDID - DEVICE: THP™ Hip Fracture Plating System (00887868164859)

GUDID

Device Identifier (DI) Information

Brand Name: THP™ Hip Fracture Plating System
Version or Model: 14-451570
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 14-451570
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00887868164859
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:	No
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?
33542	Bone hook	A hand-held, surgical instrument used for hooking around or into bone, typically to grasp, hold, and apply traction to the bone during a surgical intervention. It is a shaft-like instrument with a robust design and can have a singular hook or multiple hooks at the distal end and a handle of various designs at the proximal end. It is made of high-grade stainless steel. It is sometimes called a bone retractor. This is a reusable device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140018	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: f2c8925c-fb21-4b92-a5e3-c99a139a6824
Public Version Date: May 30, 2025
Public Version Number: 5
DI Record Publish Date: December 29, 2017