Latitud Hip Replacement System— 510(k) K222436
Substantially EquivalentMeril Healthcare Pvt. , Ltd.
FDA 510(k) clearance K222436 for Latitud Hip Replacement System, Substantially Equivalent on 2023-05-09. Applicant: Meril Healthcare Pvt. , Ltd.. Device class: 2.
Clearance details
- Applicant
- Meril Healthcare Pvt. , Ltd.
- Product code
- Code LPH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3358
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vapi, IN
Recent devices under product code LPH
view allMore clearances from Meril Healthcare Pvt. , Ltd.
view all- K222816 — Opulent TiNbN Coated Knee
- K212839 — Opulent TiNbN Coated Knee
- K183532 — Latitud Hip Replacement System
- K172857 — Latitud Hip Replacement System
- K171320 — ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws
Adverse events under product code LPH
product code LPH- Death
- 73
- Injury
- 31,640
- Malfunction
- 3,358
- Other
- 2
- Total
- 35,073
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.