Kestrel®

FDA UDI

Class II (US FDA UDI)

by Innovasis, Inc.

Identity

Trade Name: Kestrel® FDA UDI
Generic Name: Manual orthopaedic bender, reusable FDA UDI
Device Name: SST FDA UDI
Model / Reference: LS-452 FDA UDI
Description: SST FDA UDI

Identifiers

Catalog Number: LS-452 FDA UDI
Primary DI / UDI-DI: M711LS4520 FDA UDI
510(k) Number: K181063 FDA UDI
FDA Product Code: KWQ FDA UDI
GMDN Term: Manual orthopaedic bender, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Manual orthopaedic bender, reusable

Kestrel® by Innovasis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Manual orthopaedic bender, reusable.

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Dark Star Deformity — Republic Spine, LLC · Class II
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CLAW CHARLOTTE — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I

Cleared under the same submission

K181063 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: Innovasis, Inc.

Sources (1)

FDA UDI c72747dc-191c-42c9-85b1-3712132aef93 36 fields · synced May 30, 2026