FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
ARROW Anatomical Porous glenoid
K Number: K162068
·
Decision Apr 10, 2017
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
36
Applicant Total
24
Review Days
258
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Basic Information
- Device Name
- ARROW Anatomical Porous glenoid
- K Number
- K162068
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3670
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fournitures Hospitalieres Industrie
- Date Received
- July 26, 2016
- Decision Date
- April 10, 2017
- Product Code
- MBF
- 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 |
|---|---|---|---|
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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Other Clearances by Fournitures Hospitalieres Industrie
| K Number | Device Name | ||
|---|---|---|---|
| K171789 | ARROW Reverse Porous Glenoid | Jan 23, 2018 | Substantially Equivalent |
| K163148 | BePOD® Foot Screws | Sep 14, 2017 | Substantially Equivalent |
| K163710 | BePOD® EZ Weil Screws | Sep 8, 2017 | Substantially Equivalent |
| K170040 | BePOD Cannulated Arthrodesis Screws | Apr 4, 2017 | Substantially Equivalent |
| K150568 | ARROW Humeral stems size 6 and 16 | Oct 29, 2015 | Substantially Equivalent |
| K150471 | CalcaNail Orthopedic Arthrodesis Nail | May 22, 2015 | Substantially Equivalent |
| K150463 | CalcaNail Orthopedic Nail | May 22, 2015 | Substantially Equivalent |
| K142778 | ARROW Reverse Shoulder long keel and short keel glenoid base | Mar 20, 2015 | Substantially Equivalent |
| K120740 | COLS® FIXATION SYSTEM | Mar 5, 2013 | Substantially Equivalent |
| K112193 | ARROW REVERSE SHOULDER SYSTEM | Jul 12, 2012 | Substantially Equivalent |