PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS— 510(k) K924381
Substantially Equivalent for Some IndicationsCross Medical Products, Inc.
FDA 510(k) clearance K924381 for PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS, Substantially Equivalent for Some Indications on 1993-05-18. Applicant: Cross Medical Products, Inc..
Clearance details
- Applicant
- Cross Medical Products, Inc.
- Product code
- Code KWP
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Concord, CA, US
Adverse events under product code KWP
product code KWP- Death
- 7
- Injury
- 1,539
- Malfunction
- 1,519
- Total
- 3,065
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.