DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM
FDA 510(k) clearance K140038 · decided 2014-05-27
Clearance details
- K-number
- K140038
- Device name
- DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM
- Applicant
- Curexo Technology Corporation
- Decision
- Substantially Equivalent
- Date received
- 2014-01-07
- Decision date
- 2014-05-27
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- OJP
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Melrose, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TSolution One w/ACG surgical System (K150741) | THINK Surgical, Inc. | 2015-10-22 |
| CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM (K140585) | Curexo Technology Corporation | 2014-08-18 |
| DIGIMATCH ROBODOC SURGICAL SYSTEM (K072629) | Integrated Surgical Systems, Inc. | 2008-08-06 |
Recalls involving this device
No recalls on record reference this clearance.