Identity
- Trade Name
- CT Motion Rod, 54 inch FDA UDI
- Generic Name
- Robotic surgical arm system FDA UDI
- Model / Reference
- 103449 FDA UDI
Identifiers
- Catalog Number
- 103449 FDA UDI
- Primary DI / UDI-DI
- M9461034491 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Robotic surgical arm 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
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
Category: Robotic surgical arm system
CT Motion Rod, 54 inch by Think Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Robotic surgical arm system.
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- Flex — Medrobotics Corporation · Class II
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- FLEX — Medrobotics Corporation · Class II
- Senhance — Asensus Surgical, Inc. · Class II
- ARTAS System — Venus Concept Inc. · Class II
Cleared under the same submission
K230202 also covers:
- Angel Wing — Think Surgical Inc.
- Array Guide — Think Surgical Inc.
- CT Motion Rod, 42 inch — Think Surgical Inc.
- Digitizer — Think Surgical Inc.
- Femur Tracking Array — Think Surgical Inc.
- Pin Puller — Think Surgical Inc.
- Square Driver — Think Surgical Inc.
- TMINI® Guide Block Kit for LINK® LinkSymphoKnee System — Think Surgical Inc.
- TMINI® Guide Block Kit for LINK® LinkSymphoKnee System (10ea) — Think Surgical Inc.
- TMINI® Guide Block Kit for Maxx Ortho Freedom® Total & Titan Knee — Think Surgical Inc.
- TMINI® Guide Block Kit for Maxx Ortho Freedom® Total & Titan Knee (10ea) — Think Surgical Inc.
- TMINI® Guide Block Kit for Medacta® Knee System — Think Surgical Inc.
K232802 also covers:
- Angel Wing — Think Surgical Inc.
- Array Guide — Think Surgical Inc.
- CT Motion Rod, 42 inch — Think Surgical Inc.
- Digitizer — Think Surgical Inc.
- Femur Tracking Array — Think Surgical Inc.
- Pin Puller — Think Surgical Inc.
- Square Driver — Think Surgical Inc.
- TMINI® Guide Block Kit for LINK® LinkSymphoKnee System — Think Surgical Inc.
- TMINI® Guide Block Kit for LINK® LinkSymphoKnee System (10ea) — Think Surgical Inc.
- TMINI® Guide Block Kit for Maxx Ortho Freedom® Total & Titan Knee — Think Surgical Inc.
- TMINI® Guide Block Kit for Maxx Ortho Freedom® Total & Titan Knee (10ea) — Think Surgical Inc.
- TMINI® Guide Block Kit for Medacta® Knee System — Think Surgical Inc.
K241031 also covers:
- Angel Wing — Think Surgical Inc.
- Array Guide — Think Surgical Inc.
- CT Motion Rod, 42 inch — Think Surgical Inc.
- Digitizer — Think Surgical Inc.
- Femur Tracking Array — Think Surgical Inc.
- Pin Puller — Think Surgical Inc.
- Square Driver — Think Surgical Inc.
- TMINI® Guide Block Kit for LINK® LinkSymphoKnee System — Think Surgical Inc.
- TMINI® Guide Block Kit for LINK® LinkSymphoKnee System (10ea) — Think Surgical Inc.
- TMINI® Guide Block Kit for Maxx Ortho Freedom® Total & Titan Knee — Think Surgical Inc.
- TMINI® Guide Block Kit for Maxx Ortho Freedom® Total & Titan Knee (10ea) — Think Surgical Inc.
- TMINI® Guide Block Kit for Medacta® Knee System — Think Surgical 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Think Surgical Inc.
Sources (1)
- FDA UDI db2a6f47-c680-41a8-8177-242099d6bb5f 35 fields · synced Jun 8, 2026