Identity
- Trade Name
- Navigation Unit Kit FDA UDI
- Generic Name
- Orthopaedic stereotactic surgery system FDA UDI
- Model / Reference
- GS004 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09360506000111 FDA UDI
- 510(k) Number
- K243387 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
No
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
Yes
FDA UDI
Category: Orthopaedic stereotactic surgery system
Navigation Unit Kit by Gyder Surgical Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic stereotactic surgery system.
- TRIGEN — Smith & Nephew, Inc. · Class II
- PULSE — Nuvasive, Inc. · Class II
- KneePlus — PIXEE MEDICAL · Class II
- intellijoint HIP® — Intellijoint Surgical Inc · Class II
- PULSE — Nuvasive, Inc. · Class II
- StealthStation S8 Spine — MEDTRONIC NAVIGATION, INC. · Class II
- WatchTower — Intai Technology Corporation · Class II
- KneePlus — PIXEE MEDICAL · Class II
Cleared under the same submission
K243387 also covers:
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
- Gyder Surgical Pty Ltd
Sources (1)
- FDA UDI 807e274a-e51a-4702-96bc-472eca710b86 33 fields · synced May 30, 2026