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Sternalock 360 System

FDA UDI

Class II (US FDA UDI)

by Biomet Microfixation, Inc

Identity

Trade Name
STERNALOCK 360 SYSTEM FDA UDI
Generic Name
Sternal fixation device FDA UDI
Model / Reference
74-0014 FDA UDI

Identifiers

Catalog Number
74-0014 FDA UDI
Primary DI / UDI-DI
00841036190224 FDA UDI
510(k) Number
K151019 FDA UDI
K163007 FDA UDI
FDA Product Code
HRS FDA UDI
GMDN Term
Sternal fixation device FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Sternalock 360 System by Biomet Microfixation, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K151019 also covers:

K163007 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomet Microfixation, Inc

Sources (1)

  • FDA UDI 79694ddb-1d5c-4e36-a06d-ab9979d392eb 36 fields · synced Jun 1, 2026