ACTERA hip system— 510(k) K231178
Substantially EquivalentConformis, Inc.
FDA 510(k) clearance K231178 for ACTERA hip system, Substantially Equivalent on 2023-05-23. Applicant: Conformis, Inc.. Device class: 2.
Clearance details
- Applicant
- Conformis, Inc.
- Product code
- Code MEH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3353
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Billerica, MA, US
Recent devices under product code MEH
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- K230846 — iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System
- K231233 — Identity Imprint CR KRS and Identity Imprint PS KRS
- K230844 — Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert
Adverse events under product code MEH
product code MEH- Injury
- 2,021
- Total
- 2,021
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.