Identity
- Trade Name
- STELLAR Knee FDA UDI
- Generic Name
- Orthopaedic stereotactic surgery system FDA UDI
- Device Name
- Kit, Streaming Head Mounted Device FDA UDI
- Model / Reference
- Revision 00 FDA UDI
- Description
- Kit, Streaming Head Mounted Device FDA UDI
Identifiers
- Catalog Number
- 80-0004-STREAM FDA UDI
- Primary DI / UDI-DI
- 00850046497124 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Orthopaedic stereotactic surgery system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic stereotactic surgery system
STELLAR Knee by Polarisar, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic stereotactic surgery system.
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- PULSE — Nuvasive, Inc. · Class II
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- StealthStation S8 Spine — MEDTRONIC NAVIGATION, INC. · Class II
- WatchTower — Intai Technology Corporation · Class II
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
- Polarisar, Inc.
Sources (1)
- FDA UDI 9c32f8ac-f253-4a9e-9a19-fc33f314341e 34 fields · synced Jun 1, 2026