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TopLock

FDA UDI

Class II (US FDA UDI)

by Fusion Orthopedics, Llc

Identity

Trade Name
TopLock FDA UDI
Generic Name
Cannulated surgical drill bit, single-use, non-sterile FDA UDI
Device Name
Punch 2.1 mm Long FDA UDI
Model / Reference
CD-TP-8521 FDA UDI
Description
Punch 2.1 mm Long FDA UDI

Identifiers

Catalog Number
CD-TP-8521 FDA UDI
Primary DI / UDI-DI
00840124501546 FDA UDI
FDA Product Code
MBI FDA UDI
GMDN Term
Cannulated surgical drill bit, single-use, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Cannulated surgical drill bit, single-use, non-sterile

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

Similar devices

Also classified as Cannulated surgical drill bit, single-use, non-sterile.

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 ea8cf046-5fcd-40a3-89d1-bccc7be46e85 34 fields · synced May 30, 2026