ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP; EXTRACTION TOOL— 510(k) K102262
Substantially EquivalentArthrocare Corp.
FDA 510(k) clearance K102262 for ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP; EXTRACTION TOOL, Substantially Equivalent on 2010-10-21. Applicant: Arthrocare Corp.. Device class: 2.
Clearance details
- Device name as filed
- ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL
- Applicant
- Arthrocare Corp.
- Product code
- Code MBI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
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- K111399 — SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75
- K111397 — TITAN TI SUTURE ANCHOR SYSTEM
Adverse events under product code MBI
product code MBI- Injury
- 3,163
- Malfunction
- 13,006
- Other
- 2
- Total
- 16,171
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.