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Precice

FDA UDI

Class II (US FDA UDI)

by NuVasive Specialized Orthopedics, Inc.

Identity

Trade Name
PRECICE FDA UDI
Generic Name
Arthrodesis intramedullary nail, magnetic distraction FDA UDI
Device Name
PRECICE Ankle Salvage Ti, 11.5x200mm FDA UDI
Model / Reference
AST11.5-40200 FDA UDI
Description
PRECICE Ankle Salvage Ti, 11.5x200mm FDA UDI

Identifiers

Primary DI / UDI-DI
00195377108463 FDA UDI
510(k) Number
K230765 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 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

K230765 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 afb24bd9-9f8b-47ba-87e2-c56464b9ce3e 35 fields · synced May 30, 2026