510(k) K072629
- Device
- DIGIMATCH ROBODOC SURGICAL SYSTEM
- Applicant
- INTEGRATED SURGICAL SYSTEMS, INC.
- 510(k) number
- K072629
- Product code
- OJP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-08-06
- Date received
- 2007-09-17
- 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
- RUSS HIBBERT
- Address
- 1433 N. Market Blvd., #1 Sacremento CA US 95834 95834
FDA Registration Numbers#
- 1828464
- 3003477135
- 3005061536
Source Documents#
Other 510(k) Records For Product Code OJP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150741 | TSolution One w/ACG surgical System | THINK Surgical, Inc. | 2015-10-22 |
| 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 |
Legacy Summary#
summary
FDA Review#
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