Novo Surgical Inc.

FDA UDI

Class I (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name: Novo Surgical Inc. FDA UDI
Generic Name: Bone lever/elevator, reusable FDA UDI
Device Name: cobb-type spinal elevator, solid hexagonal handle, 9 1/2" (24.0 cm), 1/2" (12.0 mm) blade FDA UDI
Model / Reference: N3761-13 FDA UDI
Description: cobb-type spinal elevator, solid hexagonal handle, 9 1/2" (24.0 cm), 1/2" (12.0 mm) blade FDA UDI

Identifiers

Catalog Number: N3761-13 FDA UDI
Primary DI / UDI-DI: 00842331135385 FDA UDI
FDA Product Code: GEG FDA UDI
GMDN Term: Bone lever/elevator, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone lever/elevator, reusable

Novo Surgical Inc. by Novo Surgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Novo Surgical, Inc.

Sources (1)

FDA UDI 3ffe1d16-31ad-499e-a054-fc5dc8852578 35 fields · synced Jun 8, 2026