Digimatch Orthodoc Robodoc Encore Surgical System
FDA 510(k) K140038 · Curexo Technology Corporation
510(k) numberK140038
Submission
- Device name
- Digimatch Orthodoc Robodoc Encore Surgical System
- Applicant
- Curexo Technology Corporation
Melrose, MA, US - Received
- January 7, 2014
- Decision date
- May 27, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OJP – Orthopedic Computer Controlled Surgical System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Specialty
- Neurology
Pre-operative planning and intra-operative execution of surgical movements with robotically controlled end effectors under user supervision. Alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).
Other 510(k)s with product code OJP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K150741 | TSolution One w/ACG surgical SystemOJP · Traditional | THINK Surgical, Inc. | 10/22/2015SE |
| K140585 | CTC Tcat(R)-Tplan(R) Surgical SystemOJP · Traditional | Curexo Technology Corporation | 08/18/2014SE |
| K072629 | Digimatch Robodoc Surgical SystemOJP · Traditional | Integrated Surgical Systems, Inc. | 08/06/2008SE |
More from Integrated Surgical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K140585 | CTC Tcat(R)-Tplan(R) Surgical SystemOJP · Traditional | 08/18/2014SE |
Questions and answers
When was Digimatch Orthodoc Robodoc Encore Surgical System cleared by the FDA?
Digimatch Orthodoc Robodoc Encore Surgical System (K140038) received a 510(k) decision of Substantially Equivalent on May 27, 2014, 140 days after the submission was received.
What is the product code of K140038?
The FDA product code is OJP – Orthopedic Computer Controlled Surgical System, a Class II (moderate risk) device regulated under 21 CFR 882.4560.