Bioplate®

Basic Information

• Brand Name: Bioplate®
• Primary DI: M384SCR80805US1
• Version / Model: SCR8-08-05[US]
• Catalog Number: SCR8-08-05[US]
• Company Name: Bioplate, Inc.
• Labeler DUNS: 838734093
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-11-08
• Public Version: 5
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: 5e4b7425-99be-47fd-8ff2-f5d4e79aab23

Device Description

Screw - Ø1.2 mm x 8 mm [5 PK]

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JEY	Plate, Bone	Dental	872.4760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46879	Cranioplasty plate screw	A small, threaded rod with a slotted head designed to fasten skull plates (i.e., plates with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult) to the intact cranial bones. It is typically made of metal [e.g., stainless steel, titanium (Ti)] and has a length and diameter appropriate to match the plate holes and the cranial bones. It is used mainly in neurosurgical procedures intended to fix cranioplasty plates used to repair defects created or caused by injury, surgical intervention for tumour removal, or congenital anomaly or disease.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M384SCR80805US1	HIBCC
Unit of Use	M384SCR80805US0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K953273	000

Device Sizes

Type	Value	Unit	Text
Length	8	Millimeter