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Sternalock® Blu System

FDA UDI

Class II (US FDA UDI)

by Biomet Microfixation, Inc

Identity

Trade Name
STERNALOCK® BLU SYSTEM FDA UDI
Generic Name
Sternal fixation device FDA UDI
Model / Reference
73-2636 FDA UDI

Identifiers

Catalog Number
73-2636 FDA UDI
Primary DI / UDI-DI
00888233000970 FDA UDI
510(k) Number
K011076 FDA UDI
K121302 FDA UDI
K161896 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
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Sternal fixation device

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

Similar devices

Also classified as Sternal fixation device.

Cleared under the same submission

K011076 also covers:

K121302 also covers:

K161896 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 704e36f5-e198-4ac4-8162-e184bbda586a 35 fields · synced May 30, 2026