FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORTHOREX INTRA-OPERATIVE LOAD SENSOR
K Number: K090474
·
Decision Oct 19, 2009
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
14
Applicant Total
3
Review Days
237
Basic Information
- Device Name
- ORTHOREX INTRA-OPERATIVE LOAD SENSOR
- K Number
- K090474
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ORTHOSENSOR, INC.
- Date Received
- February 24, 2009
- Decision Date
- October 19, 2009
- Product Code
- ONN
- 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 |
|---|---|---|---|
| ONN | Intraoperative Orthopedic Joint Assessment Aid | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ONN), ordered by most recent decision date.
QUADSENSE
FDA 510(k)
FDA Class 2
·Neurology
Lantern® Hip
FDA 510(k)
FDA Class 2
·Neurology
TrueBalance Surgical System
FDA 510(k)
FDA Class 2
·Neurology
VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder
FDA 510(k)
FDA Class 2
·Neurology
VERASENSE for Stryker Triathlon
FDA 510(k)
FDA Class 2
·Neurology
VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left
FDA 510(k)
FDA Class 2
·Neurology