AccessGUDID - DEVICE: PRECICE® Plating System (00887517021663)

GUDID

Device Identifier (DI) Information

Brand Name: PRECICE® Plating System
Version or Model: LP4.5-MRT31
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LP4.5-MRT31
Company Name: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Primary DI Number: 00887517021663
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 837845234 *Terms of Use

Device Description: PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 35mm, 1-Hole

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	Yes
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?
64673	Long bone distraction plate, magnetic	An implantable device in the form of a plate, capable of adjusting in length, designed to be attached to 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; each plate is specific to a particular long bone (e.g., femur, humerus, tibia). It consists of overlapping plates, 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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HRS	Plate, Fixation, Bone
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192181	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 4c2cb60c-d955-4a1b-bdfa-6fd7be4cca9b
Public Version Date: May 28, 2025
Public Version Number: 4
DI Record Publish Date: January 06, 2020