Memometal Fixos Screws
FDA 510(k) K070039 · Memometal Technologies
510(k) numberK070039
Submission
- Device name
- Memometal Fixos Screws
- Applicant
- Memometal Technologies
Bruz, FR - Received
- January 3, 2007
- Decision date
- March 21, 2007
- 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 |
|---|---|---|
| K112197 | Memometal Intra-Medullary Bone FastenerHTY · Special | 11/17/2011SE |
| K101930 | Memometal Navis Bone Plating SystemHRS · Traditional | 03/15/2011SE |
| K102072 | Memometal Implants (K-Snap & Ti-Fuse)HTY · Traditional | 11/03/2010SE |
| K093820 | Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115HWC · Traditional | 05/19/2010SE |
| K083447 | Memometal Anchorage Bone Plate System, Models Plss/Plsl, PLP10/PLP20/PLP30/PLP40/PLP50HRS · Traditional | 02/06/2009SE |
| K071941 | Memometal Bone AnchorsHWC · Traditional | 12/04/2007SE |
| K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseHTY · Traditional | 07/26/2007SE |
| K070033 | Memometal Varisation, Models AV26-08, AV26-10, AV90-08 and AV90-10JDR · Traditional | 03/19/2007SE |
| K070031 | Memometal Memory StaplesJDR · Traditional | 03/19/2007SE |
Questions and answers
When was Memometal Fixos Screws cleared by the FDA?
Memometal Fixos Screws (K070039) received a 510(k) decision of Substantially Equivalent on March 21, 2007, 77 days after the submission was received.
What is the product code of K070039?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.