FastFrame™

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name: FastFrame™ FDA UDI
Generic Name: Surgical screwdriver, single-use FDA UDI
Model / Reference: 00-5300-050-01 FDA UDI

Identifiers

Catalog Number: 00-5300-050-01 FDA UDI
Primary DI / UDI-DI: 00889024508576 FDA UDI
510(k) Number: K151992 FDA UDI
K152484 FDA UDI
FDA Product Code: KTT FDA UDI
GMDN Term: Surgical screwdriver, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Surgical screwdriver, single-use

FastFrame™ by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Surgical screwdriver, single-use.

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Remover Screw — OSSTEM IMPLANT Co., Ltd. · Class I
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SR Tip, Φ1.0mm, L 26mm — BIO CONCEPT Co., Ltd. · Class I

Cleared under the same submission

K151992 also covers:

K152484 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: Zimmer, Inc.

Sources (1)

FDA UDI 8f2d3a77-cdc7-4f18-a784-3748e82ac6a6 35 fields · synced May 30, 2026