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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
Long bone distraction intramedullary nail, magnetic FDA UDI
Device Name
4.5mm x 25mm Screw, Fully Threaded FDA UDI
Model / Reference
TSA4.5-250-S FDA UDI
Description
4.5mm x 25mm Screw, Fully Threaded FDA UDI

Identifiers

Catalog Number
TSA4.5-250-S FDA UDI
Primary DI / UDI-DI
00887517026422 FDA UDI
510(k) Number
K193617 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
Long bone distraction intramedullary nail, magnetic 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: Long bone distraction intramedullary nail, magnetic

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

Similar devices

Also classified as Long bone distraction intramedullary nail, magnetic.

Cleared under the same submission

K193617 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 bdec2e59-de3c-4f72-8f6a-8091e754b960 37 fields · synced May 30, 2026