FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
ARROW ANATOMICAL SHOULDER SYSTEM
K Number: K093599
·
Decision Nov 24, 2010
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
189
Applicant Total
24
Review Days
369
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Basic Information
- Device Name
- ARROW ANATOMICAL SHOULDER SYSTEM
- K Number
- K093599
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fournitures Hospitalieres Industrie
- Date Received
- November 20, 2009
- Decision Date
- November 24, 2010
- Product Code
- KWS
- 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 |
|---|---|---|---|
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 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 |
| K162068 | ARROW Anatomical Porous glenoid | Apr 10, 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 |