Identity
- Trade Name
- SternaFuse® Fixation System FDA UDI
- Generic Name
- Sternal fixation device FDA UDI
- Device Name
- Variable ParaMedian Recon Base 3 Holes x 3 Rings FDA UDI
- Model / Reference
- 76-2001 FDA UDI
- Description
- Variable ParaMedian Recon Base 3 Holes x 3 Rings FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810047770190 FDA UDI
- 510(k) Number
- K202914 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
Yes
FDA UDI
Category: Sternal fixation device
SternaFuse® Fixation System by Fusion Innovations — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sternal fixation device.
- STERNALOCK® BLU SYSTEM — BIOMET MICROFIXATION, INC · Class II
- 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
- Valkyrie Thoracic Fixation System — J.M. Longyear Manufacturing, LLC · Class II
- STERNALOCK® BLU SYSTEM — BIOMET MICROFIXATION, INC · Class II
- Valkyrie Thoracic Fixation System — J.M. Longyear Manufacturing, LLC · Class II
- STERNALOCK® SYSTEM — BIOMET MICROFIXATION, INC · Class II
Cleared under the same submission
K202914 also covers:
- SternaFuse® Fixation System — FUSION INNOVATIONS
- SternaFuse® Fixation System — FUSION INNOVATIONS
- SternaFuse® Fixation System — FUSION INNOVATIONS
- SternaFuse® Fixation System — FUSION INNOVATIONS
- SternaFuse® Fixation System — FUSION INNOVATIONS
- SternaFuse® Fixation System — FUSION INNOVATIONS
- SternaFuse® Fixation System — FUSION INNOVATIONS
- SternaFuse® Fixation System — FUSION INNOVATIONS
- SternaFuse® Fixation System — FUSION INNOVATIONS
- SternaFuse® Fixation System — FUSION INNOVATIONS
- SternaFuse® Fixation System — FUSION INNOVATIONS
- SternaFuse® Fixation System — FUSION INNOVATIONS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fusion Innovations
Sources (1)
- FDA UDI e0be2f2c-7fcf-4c9c-b286-bf07adeef67e 35 fields · synced Jun 8, 2026