Identity
- Trade Name
- ROBOTIC INTEGRATION INSTRUMENTS FDA UDI
- Generic Name
- Surgical optical-tracking spatial marker connector FDA UDI
- Device Name
- ROBOTIC INTEGRATION INSTRUMENTS Core Instrument FDA UDI
- Model / Reference
- 2914-89-403 FDA UDI
- Description
- ROBOTIC INTEGRATION INSTRUMENTS Core Instrument FDA UDI
Identifiers
- Catalog Number
- 291489403 FDA UDI
- Primary DI / UDI-DI
- 10705034602349 FDA UDI
- 510(k) Number
- K233256 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Surgical optical-tracking spatial marker connector 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
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
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical optical-tracking spatial marker connector
Robotic Integration Instruments by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical optical-tracking spatial marker connector.
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- 7D Surgical Universal Clamp Large — 7D Surgical ULC · Class II
- 11-0052 7D Flex Rod Connector - ø5.5mm - 150mm — 7D Surgical ULC · Class II
- 7D Surgical Flex Array — 7D Surgical ULC · Class II
- ENVISION 3D: PEDICLE PROBE — 7D Surgical ULC · Class II
Cleared under the same submission
K233256 also covers:
- ROBOTIC INTEGRATION INSTRUMENTS — Medos International Sàrl
- ROBOTIC INTEGRATION INSTRUMENTS — Medos International Sàrl
- ROBOTIC INTEGRATION INSTRUMENTS — Medos International Sàrl
- ROBOTIC INTEGRATION INSTRUMENTS — Medos International Sàrl
- ROBOTIC INTEGRATION INSTRUMENTS — Medos International Sàrl
- ROBOTIC INTEGRATION INSTRUMENTS — Medos International Sàrl
- ROBOTIC INTEGRATION INSTRUMENTS — Medos International Sàrl
- ROBOTIC INTEGRATION INSTRUMENTS — Medos International Sàrl
- ROBOTIC INTEGRATION INSTRUMENTS — Medos International Sàrl
- ROBOTIC INTEGRATION INSTRUMENTS — Medos International Sàrl
- ROBOTIC INTEGRATION INSTRUMENTS — Medos International Sàrl
- ROBOTIC INTEGRATION INSTRUMENTS — Medos International Sàrl
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
- Medos International Sàrl
Sources (1)
- FDA UDI 0f7b5277-6cfd-4c9f-a793-5857682e7f0e 36 fields · synced May 30, 2026