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Precice® Ankle Salvage System

FDA UDI

Class II (US FDA UDI)

by NuVasive Specialized Orthopedics, Inc.

Identity

Trade Name
Precice® Ankle Salvage System FDA UDI
Generic Name
Arthrodesis intramedullary nail, magnetic distraction FDA UDI
Device Name
11.5mm, 300mm Length, Ankle Salvage FDA UDI
Model / Reference
AS11.5-40300 FDA UDI
Description
11.5mm, 300mm Length, Ankle Salvage FDA UDI

Identifiers

Primary DI / UDI-DI
00887517025098 FDA UDI
510(k) Number
K200430 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
Arthrodesis intramedullary nail, magnetic distraction 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

Category: Arthrodesis intramedullary nail, magnetic distraction

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

Similar devices

Also classified as Arthrodesis intramedullary nail, magnetic distraction.

Cleared under the same submission

K200430 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 872e7d51-471a-4c1f-97da-9cd820a43c67 35 fields · synced Jun 1, 2026