SYNTHES (USA) TIBIAL NAIL SYSTEM EX— 510(k) K040762
Substantially EquivalentSynthes (Usa)
FDA 510(k) clearance K040762 for SYNTHES (USA) TIBIAL NAIL SYSTEM EX, Substantially Equivalent on 2004-04-12. Applicant: Synthes (Usa). Device class: 2.
Clearance details
- Applicant
- Synthes (Usa)
- Product code
- Code JDS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Paoli, PA, US
Recent devices under product code JDS
view allMore clearances from Synthes (Usa)
view all- K141527 — DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM
- K131984 — SYNTHES SYNSONIC ULNA NAIL
- K121601 — SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE
- K120854 — SYNTHES VA LCP ANKLE TRAUMA SYSTEM
- K120717 — SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
Adverse events under product code JDS
product code JDS- Injury
- 1,776
- Malfunction
- 1,509
- Total
- 3,285
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 K040762
K-number listed on FDA's recall record- Z-2051-2015 — TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and non-unions.
- Z-2058-2013 — Synthes Trauma Nail System. The devices are indication for bone fixation.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040762.
Data sourced from openFDA. This site is unofficial and independent of the FDA.