MEMOMETAL INTRA-MEDULLARY BONE FASTENER— 510(k) K112197
Substantially EquivalentMemometal Technologies
FDA 510(k) clearance K112197 for MEMOMETAL INTRA-MEDULLARY BONE FASTENER, Substantially Equivalent on 2011-11-17. Applicant: Memometal Technologies. Device class: 2.
Clearance details
- Applicant
- Memometal Technologies
- Product code
- Code HTY
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bruz, FR
Recent devices under product code HTY
view allMore clearances from Memometal Technologies
view all- K101930 — MEMOMETAL NAVIS BONE PLATING SYSTEM
- K102072 — MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE)
- K093820 — SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115
- K083447 — MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50
- K071941 — MEMOMETAL BONE ANCHORS
Adverse events under product code HTY
product code HTY- Injury
- 544
- Total
- 544
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K112197
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112197.
Data sourced from openFDA. This site is unofficial and independent of the FDA.