510(k) K150741
- Device
- TSolution One W/ACG Surgical System
- Applicant
- THINK SURGICAL INC.
- 510(k) number
- K150741
- Product code
- OJP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-10-22
- Date received
- 2015-03-23
- Regulation
- 882.4560
- Classification name
- Orthopedic Computer Controlled Surgical System
- Medical specialty
- Neurology
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- IN K. MUN
- Address
- 47320 Mission Falls Ct. Fremont CA US 94539 94539
FDA Registration Numbers#
- 1828464
- 3003477135
- 3005061536
Source Documents#
Other 510(k) Records For Product Code OJP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K140585 | CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM | Curexo Technology Corporation | 2014-08-18 |
| K140038 | DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM | Curexo Technology Corporation | 2014-05-27 |
| K072629 | DIGIMATCH ROBODOC SURGICAL SYSTEM | Integrated Surgical Systems, Inc. | 2008-08-06 |
Legacy Summary#
summary
FDA Review#
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