FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESPONSE Navigation Instruments
K Number: K203573
·
Decision Feb 4, 2021
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
40
Review Days
59
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Basic Information
- Device Name
- RESPONSE Navigation Instruments
- K Number
- K203573
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OrthoPediatrics Corp.
- Date Received
- December 7, 2020
- Decision Date
- February 4, 2021
- Product Code
- OLO
- 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 |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | FDA class 2 | Neurology |
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