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NuVaMap

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name
NuVaMap FDA UDI
Generic Name
Spinal rod bending system FDA UDI
Device Name
NuVaMap O.R. C-Arm Image Converter FDA UDI
Model / Reference
8210348 FDA UDI
Description
NuVaMap O.R. C-Arm Image Converter FDA UDI

Identifiers

Primary DI / UDI-DI
00887517707291 FDA UDI
510(k) Number
K143641 FDA UDI
FDA Product Code
GWF FDA UDI
OLO FDA UDI
PDQ FDA UDI
HAW FDA UDI
IKN FDA UDI
ETN FDA UDI
GMDN Term
Spinal rod bending system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1870 FDA UDI
882.4560 FDA UDI
874.1820 FDA UDI
890.1375 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Spinal rod bending system

NuVaMap by Nuvasive, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal rod bending system.

Cleared under the same submission

K143641 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nuvasive, Inc.

Sources (1)

  • FDA UDI e1b9e046-333a-4619-84db-784dba8c6dc5 35 fields · synced May 30, 2026