INTERMEDICS SELECT SHOULDER METAL-BACKED GLENOID— 510(k) K884943
Substantially Equivalent for Some IndicationsIntermedics Orthopedics
FDA 510(k) clearance K884943 for INTERMEDICS SELECT SHOULDER METAL-BACKED GLENOID, Substantially Equivalent for Some Indications on 1989-04-27. Applicant: Intermedics Orthopedics.
Clearance details
- Applicant
- Intermedics Orthopedics
- Product code
- Code KWS
- 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 KWS
product code KWS- Death
- 6
- Injury
- 9,652
- Malfunction
- 1,385
- Other
- 1
- Total
- 11,044
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.