ARROW Anatomical Porous glenoid
FDA 510(k) K162068 · Fournitures Hospitalieres Industrie
510(k) numberK162068
Submission
- Device name
- ARROW Anatomical Porous glenoid
- Applicant
- Fournitures Hospitalieres Industrie
Quimper, FR - Received
- July 26, 2016
- Decision date
- April 10, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBF – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3670
- Specialty
- Orthopedic
- Implant
- Yes
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More from Lima Corporate S.P.A.
| 510(k) | Device | Decision |
|---|---|---|
| K171789 | ARROW Reverse Porous GlenoidPHX · Traditional | 01/23/2018SE |
| K163148 | BePOD® Foot ScrewsHWC · Traditional | 09/14/2017SE |
| K163710 | BePOD® EZ Weil ScrewsHWC · Traditional | 09/08/2017SE |
| K170040 | BePOD Cannulated Arthrodesis ScrewsHWC · Traditional | 04/04/2017SE |
| K150568 | ARROW Humeral stems size 6 and 16PHX · Traditional | 10/29/2015SE |
| K150471 | CalcaNail Orthopedic Arthrodesis NailHSB · Traditional | 05/22/2015SE |
| K150463 | CalcaNail Orthopedic NailHSB · Traditional | 05/22/2015SE |
| K142778 | ARROW Reverse Shoulder long keel and short keel glenoid basePHX · Traditional | 03/20/2015SE |
| K120740 | Cols® Fixation SystemMBI · Special | 03/05/2013SE |
| K112193 | Arrow Reverse Shoulder SystemPHX · Traditional | 07/12/2012SE |
Questions and answers
When was ARROW Anatomical Porous glenoid cleared by the FDA?
ARROW Anatomical Porous glenoid (K162068) received a 510(k) decision of Substantially Equivalent on April 10, 2017, 258 days after the submission was received.
What is the product code of K162068?
The FDA product code is MBF – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3670.