Precice®

Basic Information

• Brand Name: Precice®
• Primary DI: 00887517025005
• Version / Model: STP6-750-A
• Company Name: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
• Labeler DUNS: 837845234
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-15
• Public Version: 3
• Public Version Date: 2024-02-08
• Public Version Status: Update
• Public Device Record Key: 55e13ea9-05db-4866-ad7d-1d79ec7970a4
• Distribution End Date: 2024-02-07

Device Description

6.0mmx75mm Locking Screw, PT

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: 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
HWC	Screw, Fixation, Bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65265	Arthrodesis nail, distraction	A rod, capable of adjusting in length, designed to be inserted into the bones on both sides of a joint to fuse the joint (e.g. tibia and calcaneus for ankle arthrodesis) and to facilitate subsequent limb lengthening, in traumatic repair or reconstructive procedures. It consists of telescoping rods connected to the bone with dedicated locking screws, which have one or more integrated magnets that move in response to a noninvasive magnetic control device (not included) to adjust length. It is made of metal or other material (e.g., carbon fibre). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887517025005	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K200430	000