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PRECICE® Bone Transport System

FDA UDI

Class II (US FDA UDI)

by NuVasive Specialized Orthopedics, Inc.

Identity

Trade Name
PRECICE® Bone Transport System FDA UDI
Generic Name
Tibia intramedullary nail FDA UDI
Device Name
Antegrade Tibia 10° Bend, 10.0mm x 380mm, 5/10cm ST FDA UDI
Model / Reference
BT10-10C380-5 FDA UDI
Description
Antegrade Tibia 10° Bend, 10.0mm x 380mm, 5/10cm ST FDA UDI

Identifiers

Catalog Number
BT10-10C380-5 FDA UDI
Primary DI / UDI-DI
00887517981356 FDA UDI
510(k) Number
K182170 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
Tibia 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

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

Dimensions & Sizes

Size
Outer Diameter — 10.0 Millimeter FDA UDI

Category: Tibia intramedullary nail

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

Similar devices

Also classified as Tibia intramedullary nail.

Cleared under the same submission

K182170 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 33e3aa0c-2bc2-400c-a3da-7848528dfdec 36 fields · synced May 30, 2026