FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGIMATCH ROBODOC SURGICAL SYSTEM
K Number: K072629
·
Decision Aug 6, 2008
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
3
Applicant Total
3
Review Days
324
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DIGIMATCH ROBODOC SURGICAL SYSTEM
- K Number
- K072629
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Integrated Surgical Systems, Inc.
- Date Received
- September 17, 2007
- Decision Date
- August 6, 2008
- Product Code
- OJP
- Advisory Committee
- Neurology
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OJP | Orthopedic Computer Controlled Surgical System | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OJP), ordered by most recent decision date.
TSolution One w/ACG surgical System
FDA 510(k)
FDA Class 2
·Neurology
CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·Neurology