MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS— 510(k) K040128
Substantially EquivalentHowmedica Osteonics Corp.
FDA 510(k) clearance K040128 for MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS, Substantially Equivalent on 2004-03-26. Applicant: Howmedica Osteonics Corp.. Device class: 2.
Clearance details
- Applicant
- Howmedica Osteonics Corp.
- Product code
- Code HSD
- Device class
- Class 2
- Regulation
- 21 CFR 888.3690
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mahwah, NJ, US
Recent devices under product code HSD
view allMore clearances from Howmedica Osteonics Corp.
view all- K193429 — Exeter V40 Femoral Stem, Exeter X3 RimFit Cup
- K200782 — Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite
- K130895 — REUNION RSA SHOULDER SYSTEM
- K123604 — ABG III MONOLITHIC HIP STEM
- K122015 — DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
Adverse events under product code HSD
product code HSD- Injury
- 3,425
- Malfunction
- 531
- Total
- 3,956
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.