SELECT SHOULDER KEELED ALL-POLY GLENOIDS— 510(k) K962238
Substantially Equivalent for Some IndicationsIntermedics Orthopedics
FDA 510(k) clearance K962238 for SELECT SHOULDER KEELED ALL-POLY GLENOIDS, Substantially Equivalent for Some Indications on 1996-08-09. Applicant: Intermedics Orthopedics.
Clearance details
- Applicant
- Intermedics Orthopedics
- Product code
- Code KWT
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Austin, TX, US
Adverse events under product code KWT
product code KWT- Injury
- 2,467
- Other
- 2
- Total
- 2,469
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.