FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
ExactechGPS Total Shoulder Application, Equinoxe Planning Software
K Number: K213546
·
Decision Jan 6, 2022
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
9
Review Days
59
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Basic Information
- Device Name
- ExactechGPS Total Shoulder Application, Equinoxe Planning Software
- K Number
- K213546
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Blue Ortho
- Date Received
- November 8, 2021
- Decision Date
- January 6, 2022
- 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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Other Clearances by Blue Ortho
| K Number | Device Name | ||
|---|---|---|---|
| K233299 | ExactechGPS® System | Jan 26, 2024 | Substantially Equivalent |
| K232521 | ExactechGPS® Total Ankle Application | Nov 16, 2023 | Substantially Equivalent |
| K213877 | ExactechGPS® System | May 2, 2022 | Substantially Equivalent |
| K193618 | ExactechGPS System | Sep 2, 2020 | Substantially Equivalent |
| K173372 | ExactechGPS Total Shoulder Application | Nov 24, 2017 | Substantially Equivalent |
| K162567 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | Apr 5, 2017 | Substantially Equivalent |
| K152764 | EXACTECH GPS | Jul 13, 2016 | Substantially Equivalent |
| K100742 | EXACTECH GPS | Oct 21, 2010 | Substantially Equivalent |