MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM— 510(k) K970896
Substantially EquivalentETHICON, Inc.
FDA 510(k) clearance K970896 for MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM, Substantially Equivalent on 1997-06-09. Applicant: ETHICON, Inc.. Device class: 2.
Clearance details
- Applicant
- ETHICON, Inc.
- Product code
- Code MAI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerville, NJ, US
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Adverse events under product code MAI
product code MAI- Injury
- 1,948
- Malfunction
- 8,580
- Total
- 10,528
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.