Precice

Basic Information

• Brand Name: Precice
• Primary DI: 00887517028808
• Version / Model: LSC5-400-S
• Catalog Number: LSC5-400-S
• Company Name: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
• Labeler DUNS: 837845234
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-16
• Public Version: 3
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: ba257f01-7419-4c84-abc7-0c6bc623f513

Device Description

5.0mm x 40mm Screw, Peg

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
63367	Long bone distraction nail, magnetic	An implantable device in the form of a rod, capable of adjusting in length, designed to be inserted into the medullary cavity of a long bone to hold the ends of a fractured bone in position to promote healing, or to support the bone in the presence of a pathological condition, or for limb lengthening procedures (not related to arthrodesis); each rod (nail) is specific to a particular long bone (e.g., femur, humerus, tibia). It consists of telescoping rods connected to the bone by locking screws, which have one or more integrated magnets that move in response to a noninvasive magnetic control device to adjust length.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887517028808	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K193617	000