BETACONE HIP PROSTHESIS SYSTEM— 510(k) K051826
Substantially EquivalentWaldemar Link GmbH & Co. KG
FDA 510(k) clearance K051826 for BETACONE HIP PROSTHESIS SYSTEM, Substantially Equivalent on 2005-11-18. Applicant: Waldemar Link GmbH & Co. KG. Device class: 2.
Clearance details
- Applicant
- Waldemar Link GmbH & Co. KG
- 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
- Philadelphia, PA, US
Recent devices under product code LWJ
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view all- K261009 — MobileLink Acetabular Cup System 40mm ID Inserts (various)
- K250375 — Allure Hip Stem and Intramedullary Plugs
- K243927 — MobileLink Acetabular Cup System - inhouse coatings
- K241636 — MobileLink Acetabular Cup System - Line Extension (Multiple)
- K231445 — LINK Embrace Shoulder System - Reverse Configuration
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.