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SternaFuse Fixation System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K202914

by Fusion Innovations, LLC

Identity

Trade Name
SternaFuse® Fixation System FDA UDI
Generic Name
Sternal fixation device FDA UDI
Device Name
Locking Screw 4-Pack Ø3.0mm X 16mm, Cancellous, Self-Drilling FDA UDI
Model / Reference
76-3016-4 FDA UDI
Description
Locking Screw 4-Pack Ø3.0mm X 16mm, Cancellous, Self-Drilling FDA UDI

Identifiers

Primary DI / UDI-DI
00810047770060 FDA UDI
510(k) Number
K202914 FDA 510(k)FDA UDI
FDA Product Code
HRS FDA 510(k)
HWC FDA UDI
GMDN Term
Sternal fixation device FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3030 FDA 510(k)
Regulation Number
888.3030 FDA 510(k)
888.3040 FDA UDI
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Dimensions & Sizes

Size
Outer Diameter — 3.0 Millimeter FDA UDI
Length — 16 Millimeter FDA UDI

SternaFuse Fixation System by Fusion Innovations, LLC — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Fusion Innovations, LLC

Sources (2)

  • FDA 510(k) K202914 24 fields · synced Jun 19, 2026
  • FDA UDI 5cb9fd83-7fcd-45c2-9a37-c99a4b789483 36 fields · synced May 27, 2026