GENESIS II CONSTRAINED SYSTEM— 510(k) K962137
Substantially EquivalentSmith & Nephew Richards, Inc.
FDA 510(k) clearance K962137 for GENESIS II CONSTRAINED SYSTEM, Substantially Equivalent on 1996-08-02. Applicant: Smith & Nephew Richards, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew Richards, 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
- Memphis, TN, US
Recent devices under product code JWH
view allMore clearances from Smith & Nephew Richards, 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 K962137
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 K962137.
Data sourced from openFDA. This site is unofficial and independent of the FDA.