PolyLock Small Bone

FDA UDI

Class II (US FDA UDI)

by Fusion Orthopedics, Llc

Identity

Trade Name: PolyLock Small Bone FDA UDI
Generic Name: Instrument tray, reusable FDA UDI
Device Name: Lapidus Implant Caddy FDA UDI
Model / Reference: TN-TR-0060 FDA UDI
Description: Lapidus Implant Caddy FDA UDI

Identifiers

Catalog Number: TN-TR-0060 FDA UDI
Primary DI / UDI-DI: 00840124520752 FDA UDI
510(k) Number: K211843 FDA UDI
FDA Product Code: HJO FDA UDI
GMDN Term: Instrument tray, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.1850 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Instrument tray, reusable

Discover the PolyLock Small Bone, a versatile instrument tray designed for medical professionals to efficiently manage and sterilize instruments during clinical procedures. With its compact design and durable construction, this reusable device is ideal for use in various medical specialties.

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Cleared under the same submission

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: Fusion Orthopedics, Llc

Sources (1)

FDA UDI 2fc726ea-257b-4a3d-8696-7225027031eb 35 fields · synced Jun 25, 2026