PRECICE® STRYDE System

Basic Information

• Brand Name: PRECICE® STRYDE System
• Primary DI: 00887517951014
• Version / Model: PS10.0-80C365
• Catalog Number: PS10.0-80C365
• Company Name: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
• Labeler DUNS: 837845234
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-25
• Public Version: 2
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: 0e1bf023-04b7-49f8-9097-26ff99e2ff4c

Device Description

Antegrade Tibia 10° Bend

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	888.3020	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38152	Tibia nail	A rod made of metal or other material intended to be implanted into the intramedullary canal of the tibia to immobilize the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887517951014	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K180503	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	10.0	Millimeter