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 Kit, 15cm Hip Pin Non-fiducial FDA UDI
Model / Reference: 5050415 FDA UDI
Description: PULSE Kit, 15cm Hip Pin Non-fiducial FDA UDI

Identifiers

Primary DI / UDI-DI: 00195377060761 FDA UDI
510(k) Number: K210574 FDA UDI
FDA Product Code: HAW FDA UDI
LLZ FDA UDI
GWF FDA UDI
OWB FDA UDI
IKN FDA UDI
ETN FDA UDI
OLO FDA UDI
PDQ FDA UDI
GMDN Term: Orthopaedic stereotactic surgery system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
892.2050 FDA UDI
882.1870 FDA UDI
892.1650 FDA UDI
890.1375 FDA UDI
874.1820 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation 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.

TRIGEN — Smith & Nephew, Inc. · Class II
KneePlus — PIXEE MEDICAL · Class II
intellijoint HIP® — Intellijoint Surgical Inc · Class II
Navigation Unit Kit — GYDER SURGICAL PTY LTD · Class II
StealthStation S8 Spine — MEDTRONIC NAVIGATION, INC. · Class II
WatchTower — Intai Technology Corporation · Class II
KneePlus — PIXEE MEDICAL · Class II
WatchTower — Intai Technology Corporation · Class I

Cleared under the same submission

K210574 also covers:

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, Inc.

Sources (1)

FDA UDI f8b20b74-e0c9-41e9-a7fd-781e01edd052 35 fields · synced Jun 8, 2026