Memometal Navis Bone Plating System
FDA 510(k) K101930 · Memometal Technologies
510(k) numberK101930
Submission
- Device name
- Memometal Navis Bone Plating System
- Applicant
- Memometal Technologies
Bruz, FR - Received
- July 9, 2010
- Decision date
- March 15, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HRS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261647 | Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional | Pace Surgical | 09/03/2026SE |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional | Ortler Global Tibbi Gerecler Anonim Sirketi | 08/28/2026SE |
| K262537 | Versalock Sterile Plating SystemHRS · Special | GM Dos Reis Industria e Comercio Ltda. | 08/19/2026SE |
| K260277 | Mikron Trauma Bone Plate& Screw SystemHRS · Traditional | Mikron Makina San. ve Tic. Ltd. Sti. | 08/13/2026SE |
| K261511 | Xpert AnkleHRS · Traditional | Newclip Technics | 07/28/2026SE |
| K261406 | Versalock Proximal Tibial Plating SystemHRS · Traditional | GM Dos Reis Industria e Comercio Ltda. | 07/21/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | TriMed, Inc. | 07/16/2026SE |
| K261191 | Alians Elbow SHRS · Traditional | Newclip Technics | 07/08/2026SE |
| K261054 | RibPlate SystemHRS · Traditional | Stryker Leibinger GmbH & Co KG | 07/01/2026SE |
| K261351 | SALGINA 2.5mm Distal Radius SystemHRS · Traditional | Bonebridge AG | 06/26/2026SE |
More from Bonebridge AG
| 510(k) | Device | Decision |
|---|---|---|
| K112197 | Memometal Intra-Medullary Bone FastenerHTY · Special | 11/17/2011SE |
| 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 |
| K070039 | Memometal Fixos ScrewsHWC · Traditional | 03/21/2007SE |
| 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 Navis Bone Plating System cleared by the FDA?
Memometal Navis Bone Plating System (K101930) received a 510(k) decision of Substantially Equivalent on March 15, 2011, 249 days after the submission was received.
What is the product code of K101930?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.