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Pulse

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name
PULSE FDA UDI
Generic Name
Orthopaedic stereotactic surgery system FDA UDI
Device Name
PULSE Confirmation Block FDA UDI
Model / Reference
5050185 FDA UDI
Description
PULSE Confirmation Block FDA UDI

Identifiers

Primary DI / UDI-DI
00195377049186 FDA UDI
510(k) Number
K210574 FDA UDI
FDA Product Code
OWB FDA UDI
HAW FDA UDI
IKN FDA UDI
JAA FDA UDI
PDQ FDA UDI
OLO FDA UDI
LLZ FDA UDI
GWF FDA UDI
ETN FDA UDI
GMDN Term
Orthopaedic stereotactic surgery system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1650 FDA UDI
882.4560 FDA UDI
890.1375 FDA UDI
874.1820 FDA UDI
892.2050 FDA UDI
882.1870 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic stereotactic surgery system

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

Similar devices

Also classified as Orthopaedic stereotactic surgery system.

Cleared under the same submission

K210574 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 d1308c3b-531e-4f4f-a109-d28be4bd4c94 35 fields · synced Jun 8, 2026