REFLECTION 3 ACETABULAR SYSTEM— 510(k) K061253
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K061253 for REFLECTION 3 ACETABULAR SYSTEM, Substantially Equivalent on 2006-05-31. Applicant: Smith & Nephew, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Code MBL
- Device class
- Class 2
- Regulation
- 21 CFR 888.3358
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Memphis, TN, US
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- K254084 — AETOS Shoulder System - CONCELOC Glenoids
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Adverse events under product code MBL
product code MBL- Injury
- 439
- Total
- 439
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.