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External Remote Controller

FDA UDI

Class II (US FDA UDI)

by NuVasive Specialized Orthopedics, Inc.

Identity

Trade Name
External Remote Controller FDA UDI
Generic Name
Distraction implant adjustment remote control FDA UDI
Device Name
PRECICE ERC 3P Shipping Pkg US FDA UDI
Model / Reference
ERC 3P FDA UDI
Description
PRECICE ERC 3P Shipping Pkg US FDA UDI

Identifiers

Catalog Number
EAD-P3-010 FDA UDI
Primary DI / UDI-DI
00887517001344 FDA UDI
510(k) Number
K170169 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
Distraction implant adjustment remote control 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
MRI Safety
MR Unsafe FDA UDI

Category: Distraction implant adjustment remote control

External Remote Controller by NuVasive Specialized Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Distraction implant adjustment remote control.

Cleared under the same submission

K170169 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 840dc9c3-af42-494a-8ee9-0a39a6cbd4cf 38 fields · synced May 30, 2026