PRECICE® Intramedullary Limb Lengthening System

FDA UDI

Class II (US FDA UDI)

by NuVasive Specialized Orthopedics, Inc.

Identity

Trade Name: PRECICE® Intramedullary Limb Lengthening System FDA UDI
Generic Name: Femur intramedullary nail FDA UDI
Device Name: Orthopedic Intramedullary Limb Lengthening Rod, Retrograde Femur Trochanteric, 10° Bend, 10.7 mm Diameter, 175 mm FDA UDI
Model / Reference: P10.7-50M175 FDA UDI
Description: Orthopedic Intramedullary Limb Lengthening Rod, Retrograde Femur Trochanteric, 10° Bend, 10.7 mm Diameter, 175 mm FDA UDI

Identifiers

Catalog Number: P10.7-50M175 FDA UDI
Primary DI / UDI-DI: 00812258028244 FDA UDI
510(k) Number: K160325 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Femur intramedullary nail 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 10.7 Millimeter FDA UDI

Category: Femur intramedullary nail

PRECICE® Intramedullary Limb Lengthening System by NuVasive Specialized Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Femur intramedullary nail.

GAMMA — Stryker Corp. · Class II
A.R.T.™FEMORAL NAIL — Biomet Orthopedics, Inc. · Class II
T2 ALPHA — Stryker Corp. · Class II
T2 — Stryker Corp. · Class II
130° Ga-mma Nail — Auxein Medical Private Limited · Class II
ARIX Femur Nail System — Jeil Medical Corporation · Class II
INTERTAN — Smith & Nephew, Inc. · Class II
TRIGEN — Smith & Nephew, Inc. · Class II

Cleared under the same submission

K160325 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: NuVasive Specialized Orthopedics, Inc.

Sources (1)

FDA UDI 3cfc7bf9-5139-4f7a-a5cc-2994f5fdadd7 37 fields · synced May 31, 2026