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: Bone nail end-cap FDA UDI
Device Name: Packaged End Cap 8.5-10.7mm 10mm FDA UDI
Model / Reference: CPA2-010 FDA UDI
Description: Packaged End Cap 8.5-10.7mm 10mm FDA UDI

Identifiers

Catalog Number: CPA2-010 FDA UDI
Primary DI / UDI-DI: 00887517001153 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Bone nail end-cap 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 10.7 Millimeter FDA UDI
Outer Diameter — 8.5 Millimeter FDA UDI

Category: Bone nail end-cap

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: NuVasive Specialized Orthopedics, Inc.

Sources (1)

FDA UDI 5305a2f6-a8b5-4280-9d1a-c2e28c9de15a 36 fields · synced Jun 8, 2026