BePOD® EZ Weil Screws
FDA 510(k) K163710 · Fournitures Hospitalieres Industrie
510(k) numberK163710
Submission
- Device name
- BePOD® EZ Weil Screws
- Applicant
- Fournitures Hospitalieres Industrie
Quimper Finistere, FR - Received
- December 30, 2016
- Decision date
- September 8, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K171789 | ARROW Reverse Porous GlenoidPHX · Traditional | 01/23/2018SE |
| K163148 | BePOD® Foot ScrewsHWC · Traditional | 09/14/2017SE |
| K162068 | ARROW Anatomical Porous glenoidMBF · Traditional | 04/10/2017SE |
| 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 BePOD® EZ Weil Screws cleared by the FDA?
BePOD® EZ Weil Screws (K163710) received a 510(k) decision of Substantially Equivalent on September 8, 2017, 252 days after the submission was received.
What is the product code of K163710?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.