Exactech Optetrak Logic CC— 510(k) K150890
Substantially EquivalentExactech, Inc.
FDA 510(k) clearance K150890 for Exactech Optetrak Logic CC, Substantially Equivalent on 2015-05-29. Applicant: Exactech, Inc.. Device class: 2.
Clearance details
- Applicant
- Exactech, Inc.
- Product code
- Code JWH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3560
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gainesville, FL, US
Recent devices under product code JWH
view allMore clearances from Exactech, Inc.
view allAdverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
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 K150890
K-number listed on FDA's recall record- Z-0583-2024 — Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
- Z-1364-2020 — Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, stems, augments, and surgical instrumentation for use in primary and revision total knee arthroplasty.
- Z-3209-2018 — Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.
- Z-2704-2017 — Exactech Optetrak Logic CC 15mm Tibial Augment Screws
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150890.
Data sourced from openFDA. This site is unofficial and independent of the FDA.