BIOSURE REGENESORB interference Screw— 510(k) K142948
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K142948 for BIOSURE REGENESORB interference Screw, Substantially Equivalent on 2015-01-13. Applicant: Smith & Nephew, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew, 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
- Andover, MA, US
Recent devices under product code MAI
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- K254084 — AETOS Shoulder System - CONCELOC Glenoids
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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 →
Recalls naming K142948
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142948.
Data sourced from openFDA. This site is unofficial and independent of the FDA.