FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
INTELLIJOINT HIP
K Number: K133759
·
Decision Jul 23, 2014
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
7
Review Days
224
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Basic Information
- Device Name
- INTELLIJOINT HIP
- K Number
- K133759
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intellijoint Surgical, Inc.
- Date Received
- December 11, 2013
- Decision Date
- July 23, 2014
- 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 Intellijoint Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K211876 | Intellijoint VIEW | Nov 12, 2021 | Substantially Equivalent |
| K191507 | Intellijoint® Navigation System | Oct 1, 2019 | Substantially Equivalent |
| K172849 | Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray | Nov 16, 2017 | Substantially Equivalent |
| K171525 | Intellijoint HIP Generation 2B System | Oct 30, 2017 | Substantially Equivalent |
| K162364 | Intellijoint HIP Generation 2A System | Mar 2, 2017 | Substantially Equivalent |
| K151364 | Intellijoint HIP(tm) System | Dec 28, 2015 | Substantially Equivalent |