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PRECICE® Trauma Nail System

FDA UDI

Class II (US FDA UDI)

by NuVasive Specialized Orthopedics, Inc.

Identity

Trade Name
PRECICE® Trauma Nail System FDA UDI
Generic Name
Surgical instrument handle, non-torque-limiting FDA UDI
Device Name
Locking Key, Long FDA UDI
Model / Reference
LKL1-000 FDA UDI
Description
Locking Key, Long FDA UDI

Identifiers

Catalog Number
LKL1-000 FDA UDI
Primary DI / UDI-DI
00812258028329 FDA UDI
510(k) Number
K152370 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
Surgical instrument handle, non-torque-limiting FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3020 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Surgical instrument handle, non-torque-limiting

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

Similar devices

Also classified as Surgical instrument handle, non-torque-limiting.

Cleared under the same submission

K152370 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 977ffbfc-4c2f-417b-9b5c-039211ad6466 37 fields · synced Jun 1, 2026