Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse
FDA 510(k) K070598 · Memometal Technologies
510(k) numberK070598
Submission
- Device name
- Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse
- Applicant
- Memometal Technologies
Bruz, FR - Received
- March 2, 2007
- Decision date
- July 26, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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More from OSSIO , Ltd.
| 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 |
| 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 Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse cleared by the FDA?
Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse (K070598) received a 510(k) decision of Substantially Equivalent on July 26, 2007, 146 days after the submission was received.
What is the product code of K070598?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.