DIGIMATCH ROBODOC SURGICAL SYSTEM
FDA 510(k) clearance K072629 · decided 2008-08-06
Clearance details
- K-number
- K072629
- Device name
- DIGIMATCH ROBODOC SURGICAL SYSTEM
- Applicant
- Integrated Surgical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-09-17
- Decision date
- 2008-08-06
- Days to decision
- 324 days
- Clearance type
- Traditional
- Product code
- OJP
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Sacremento, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Integrated Surgical Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM (K140038) | Curexo Technology Corporation | 2014-05-27 |
Recalls involving this device
No recalls on record reference this clearance.