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TopLock

FDA UDI

Class I (US FDA UDI)

by Fusion Orthopedics, Llc

Identity

Trade Name
TopLock FDA UDI
Generic Name
General external orthopaedic fixation system implantation kit, single-use FDA UDI
Device Name
4.75mm Knotless Anchor Instrument Kit FDA UDI
Model / Reference
CD-TP-2000-S FDA UDI
Description
4.75mm Knotless Anchor Instrument Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00840124511699 FDA UDI
FDA Product Code
KDD FDA UDI
GMDN Term
General external orthopaedic fixation system implantation kit, single-use 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

Yes

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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General external orthopaedic fixation system implantation kit, single-use

TopLock by Fusion Orthopedics, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General external orthopaedic fixation system implantation kit, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fusion Orthopedics, Llc

Sources (1)

  • FDA UDI aa19055e-ba66-467e-b7ee-f71fa29f711f 33 fields · synced Jun 1, 2026