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Bendini

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name
Bendini FDA UDI
Generic Name
Spinal rod bending system FDA UDI
Device Name
Bendini Digitizer Array FDA UDI
Model / Reference
1570780 FDA UDI
Description
Bendini Digitizer Array FDA UDI

Identifiers

Primary DI / UDI-DI
00887517246837 FDA UDI
510(k) Number
K111811 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Spinal rod bending system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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: Spinal rod bending system

Bendini 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

K111811 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 464626b4-cc80-4f04-84ea-f66d481a57a1 35 fields · synced May 30, 2026