LINK® MEGASYSTEM-C®— 510(k) K151008
Substantially EquivalentWaldemar Link GmbH & Co. KG
FDA 510(k) clearance K151008 for LINK® MEGASYSTEM-C®, Substantially Equivalent on 2015-08-26. Applicant: Waldemar Link GmbH & Co. KG. Device class: 2.
Clearance details
- Applicant
- Waldemar Link GmbH & Co. KG
- Product code
- Code KRO
- Device class
- Class 2
- Regulation
- 21 CFR 888.3510
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hamburg, DE
Recent devices under product code KRO
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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 KRO
product code KRO- Death
- 19
- Injury
- 4,841
- Total
- 4,860
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 K151008
K-number listed on FDA's recall record- Z-1511-2026 — Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
- Z-1512-2026 — Endo-Model Replacement Plateau; Item Number: 15-0027/15;
- Z-1513-2026 — Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
- Z-1514-2026 — Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
- Z-1515-2026 — Endo-Model Replacement Plateau; Item Number: 15-2835/12;
- Z-1516-2026 — Endo-Model Replacement Plateau; Item Number: 15-2836/11;
- Z-1517-2026 — Endo-Model Replacement Plateau; Item Number: 15-8030/12;
- Z-1518-2026 — Endo-Model Replacement Plateau; Item Number: 15-8521/09;
- Z-1519-2026 — Endo-Model Replacement Plateau; Item Number: 15-8521/11;
- Z-1520-2026 — Endo-Model Replacement Plateau; Item Number: 15-8521/15;
- Z-1521-2026 — Endo-Model Replacement Plateau; Item Number: 15-0027/11;
- Z-1522-2026 — Endo-Model Replacement Plateau; Item Number: 15-0027/12;
- Z-1523-2026 — Endo-Model Replacement Plateau; Item Number: 15-0027/16;
- Z-0890-2026 — Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
- Z-2410-2024 — Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11, 15-2835/12, 15-2836/11, 15-2836/12, 15-2837/11, 15-2837/12, 15-2838/11, 15-2838/12, 15-3815/11, 15-3815/12, 15-3816/11, 15-3816/12, 15-3817/11, 15-3817/12, 15-3818/11, 15-3818/12, 15-8521/05, 15-8521/07, 15-8521/09, 15-8521/11, 15-8521/15, 15-8521/25, 15-8521/27, 15-8521/29, 15-8521/31, 15-8521/33
- Z-2411-2024 — Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 Tibial Component Modular, Small, W: 60mm 16-2817/35 Tibial Component Modular, Medium, W: 65mm 16-2817/37 Tibial Component Modular, Large, W: 75mm
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151008.
Data sourced from openFDA. This site is unofficial and independent of the FDA.