Identity
- Trade Name
- Tsolution One Surgical System FDA UDI
- Generic Name
- Bone cutter FDA UDI
- Device Name
- BALL CUTTER Ø6 x 268mm FDA UDI
- Model / Reference
- 105734 FDA UDI
- Description
- BALL CUTTER Ø6 x 268mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- M9461057340 FDA UDI
- 510(k) Number
- K153647 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Bone cutter 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
Yes
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
Dimensions & Sizes
- Size
- Outer Diameter — 6 Millimeter FDA UDI
Category: Bone cutter
Tsolution One Surgical System by Think Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K153647 also covers:
- Tsolution One Surgical System — Think Surgical Inc.
- Tsolution One Surgical System — Think Surgical Inc.
- Tsolution One Surgical System — Think Surgical Inc.
- Tsolution One Surgical System — Think Surgical Inc.
- Tsolution One Surgical System — Think Surgical Inc.
- Tsolution One Surgical System — Think Surgical Inc.
- Tsolution One Surgical System — Think Surgical Inc.
- Tsolution One Surgical System — Think Surgical Inc.
- Tsolution One Surgical System — Think Surgical Inc.
- Tsolution One Surgical System — Think Surgical Inc.
- Tsolution One Surgical System — Think Surgical Inc.
- Tsolution One Surgical 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 |
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Manufacturer
- Manufacturer
- Think Surgical Inc.
Sources (1)
- FDA UDI 7fe687e5-73ab-4de4-acd8-eb94d9508237 36 fields · synced May 30, 2026