ACSYS SHEARER ACETABULAR CUP PROSTHESIS— 510(k) K900435
Substantially Equivalent3M Company
FDA 510(k) clearance K900435 for ACSYS SHEARER ACETABULAR CUP PROSTHESIS, Substantially Equivalent on 1990-09-14. Applicant: 3M Company. Device class: 2.
Clearance details
- Applicant
- 3M Company
- Product code
- Code LWJ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3360
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cottae Grove, MN, US
Recent devices under product code LWJ
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- K242538 — 3M Attest Super Rapid Readout Biological Indicator 1493 +4 more
- K241959 — 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD) +3 more
- K241710 — 3M Attest Super Rapid Readout Biological Indicator 1492V +3 more
- K240717 — 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
Adverse events under product code LWJ
product code LWJ- Injury
- 544
- Total
- 544
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.