PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM— 510(k) K952687
Substantially Equivalent for Some IndicationsETHICON, Inc.
FDA 510(k) clearance K952687 for PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM, Substantially Equivalent for Some Indications on 1996-02-06. 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 for Some Indications
- 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.