Identity
- Trade Name
- STERNALOCK 360 SYSTEM FDA UDI
- Generic Name
- Sternal fixation device FDA UDI
- Model / Reference
- 74-0003 FDA UDI
Identifiers
- Catalog Number
- 74-0003 FDA UDI
- Primary DI / UDI-DI
- 00888233026598 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
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
MR Conditional FDA UDI
Category: Sternal fixation device
Sternalock 360 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.
- Vanguard® — Biomet Orthopedics, Inc. · Class I
- ARIX Sternal System Bone Screw — Jeil Medical Corporation · Class II
- ARIX Sternal System Bone Plate — Jeil Medical Corporation · Class II
- SternaFuse® Fixation System — FUSION INNOVATIONS · Class II
- Valkyrie Thoracic Fixation System — J.M. Longyear Manufacturing, LLC · Class II
- Valkyrie Thoracic Fixation System — J.M. Longyear Manufacturing, LLC · Class II
- Valkyrie Thoracic Fixation System — J.M. Longyear Manufacturing, LLC · Class II
- Valkyrie Thoracic Fixation System — J.M. Longyear Manufacturing, LLC · Class II
Cleared under the same submission
K151019 also covers:
- STERNALOCK 360 SYSTEM — BIOMET MICROFIXATION, INC
- STERNALOCK 360 SYSTEM — BIOMET MICROFIXATION, INC
- STERNALOCK 360 SYSTEM — BIOMET MICROFIXATION, INC
- STERNALOCK 360 SYSTEM — BIOMET MICROFIXATION, INC
- STERNALOCK 360 SYSTEM — BIOMET MICROFIXATION, INC
- STERNALOCK 360 SYSTEM — BIOMET MICROFIXATION, INC
- STERNALOCK 360 SYSTEM — BIOMET MICROFIXATION, INC
- STERNALOCK 360 SYSTEM — BIOMET MICROFIXATION, 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
- Biomet Microfixation, Inc
Sources (1)
- FDA UDI a95bd37d-7d2f-469f-97e5-ff69430d3b92 35 fields · synced May 30, 2026