DYNAMIC COMPRESSION SMA Staple System

FDA UDI

Class II (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name: DYNAMIC COMPRESSION SMA Staple System FDA UDI
Generic Name: Orthopaedic bone staple, non-adjustable FDA UDI
Device Name: STAPLE 8164608 8MM X 12MM 4 PRONG SMA FDA UDI
Model / Reference: 8164608 FDA UDI
Description: STAPLE 8164608 8MM X 12MM 4 PRONG SMA FDA UDI

Identifiers

Primary DI / UDI-DI: 00721902831706 FDA UDI
510(k) Number: K992928 FDA UDI
FDA Product Code: MNI FDA UDI
KWQ FDA UDI
KWP FDA UDI
MNH FDA UDI
GMDN Term: Orthopaedic bone staple, non-adjustable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
888.3060 FDA UDI
888.3050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone staple, non-adjustable

DYNAMIC COMPRESSION SMA Staple System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone staple, non-adjustable.

MotoCLIP/HiMAX Step Staple — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
Step Boss — Biomedical Enterprises, Inc. · Class II
Speed — Biomedical Enterprises, Inc. · Class II
Elite — Synthes · Class II
MotoBAND™ CP DynaForce® MTP — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
Arthrex® — Arthrex, Inc. · Class II
Speed Arc — Synthes · Class II
JAWS Nitinol Staple System — Paragon 28 · Class II

Cleared under the same submission

K992928 also covers:

DYNAMIC COMPRESSION SMA Staple System — MEDTRONIC SOFAMOR DANEK, INC.

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: Medtronic Sofamor Danek, Inc.

Sources (1)

FDA UDI b8886956-deb3-4e32-8b87-df1345bd4370 36 fields · synced Jun 1, 2026