DURACON BASEPLATES— 510(k) K936008
Substantially Equivalent for Some IndicationsHowmedica Corp.
FDA 510(k) clearance K936008 for DURACON BASEPLATES, Substantially Equivalent for Some Indications on 1995-08-09. Applicant: Howmedica Corp.. Device class: 2.
Clearance details
- Applicant
- Howmedica Corp.
- 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
- Rutherford, NJ, US
Recent devices under product code JWH
view allMore clearances from Howmedica Corp.
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 K936008
K-number listed on FDA's recall record- Z-0914-2024 — PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031
- Z-0915-2024 — LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement Product Number: 6637-4-231
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K936008.
Data sourced from openFDA. This site is unofficial and independent of the FDA.