FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERTEX Nitinol Staple System
K Number: K182943
·
Decision Apr 4, 2019
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
230
Applicant Total
10
Review Days
163
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Basic Information
- Device Name
- VERTEX Nitinol Staple System
- K Number
- K182943
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nvision Biomedical Technologies, LLC
- Date Received
- October 23, 2018
- Decision Date
- April 4, 2019
- Product Code
- JDR
- Advisory Committee
- Orthopedic
- 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 |
|---|---|---|---|
| JDR | Staple, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDR), ordered by most recent decision date.
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COGNiTiON Staple System
FDA 510(k)
FDA Class 2
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|---|---|---|---|
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| K173091 | Boundary Anterior Lumbar Buttress Plate | Dec 6, 2017 | Substantially Equivalent |
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| K162426 | nva, nvp, and nvt | Sep 29, 2016 | Substantially Equivalent |
| K161524 | Tangis Anterior Cervical Plate | Sep 2, 2016 | Substantially Equivalent |
| K142328 | nvc | Dec 23, 2014 | Substantially Equivalent |
| K142594 | nva, nvp, nvt | Nov 28, 2014 | Substantially Equivalent |