OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY— 510(k) K954208
Substantially Equivalent for Some IndicationsExactech, Inc.
FDA 510(k) clearance K954208 for OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY, Substantially Equivalent for Some Indications on 1996-02-26. 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 for Some Indications
- 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 K954208
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 K954208.
Data sourced from openFDA. This site is unofficial and independent of the FDA.