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PRECICE® Plating System

FDA UDI

Class II (US FDA UDI)

by NuVasive Specialized Orthopedics, Inc.

Identity

Trade Name
PRECICE® Plating System FDA UDI
Generic Name
Long bone distraction plate, magnetic FDA UDI
Device Name
PRECICE Plate 4.5mm Distal Femur Plate, Right, 45mm, 0-Hole FDA UDI
Model / Reference
LP4.5-DRF40 FDA UDI
Description
PRECICE Plate 4.5mm Distal Femur Plate, Right, 45mm, 0-Hole FDA UDI

Identifiers

Catalog Number
LP4.5-DRF40 FDA UDI
Primary DI / UDI-DI
00887517021793 FDA UDI
510(k) Number
K192181 FDA UDI
FDA Product Code
HRS FDA UDI
KTT FDA UDI
GMDN Term
Long bone distraction plate, magnetic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Long bone distraction plate, magnetic

PRECICE® Plating System by NuVasive Specialized Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Long bone distraction plate, magnetic.

Cleared under the same submission

K192181 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
NuVasive Specialized Orthopedics, Inc.

Sources (1)

  • FDA UDI afdf1ce9-603b-4abd-99c1-ee0673e94b6d 36 fields · synced Jun 6, 2026