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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 Software, v4.0.0-bln.eu FDA UDI
Model / Reference
1802497 FDA UDI
Description
PULSE Software, v4.0.0-bln.eu FDA UDI

Identifiers

Primary DI / UDI-DI
00195377065544 FDA UDI
510(k) Number
K210574 FDA UDI
FDA Product Code
IKN FDA UDI
PDQ FDA UDI
OWB FDA UDI
ETN FDA UDI
LLZ FDA UDI
JAA FDA UDI
HAW FDA UDI
OLO FDA UDI
GWF FDA UDI
GMDN Term
Orthopaedic stereotactic surgery system FDA UDI

Classification

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

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 fe1ef40e-5b22-4586-b158-c94c25bbe77c 35 fields · synced Jun 1, 2026