EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS— 510(k) K071676
Substantially EquivalentExactech, Inc.
FDA 510(k) clearance K071676 for EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS, Substantially Equivalent on 2007-07-19. Applicant: Exactech, Inc.. Device class: 2.
Clearance details
- Applicant
- Exactech, Inc.
- Product code
- Code KWZ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3310
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Gainesville, FL, US
Recent devices under product code KWZ
view all- K241461 — Mpact Constrained Liner
- K240639 — PINNACLETM Constrained Acetabular Liners
- K162641 — Smith & Nephew, Inc. R3 Constrained Liner
- K163497 — EXPRT Revision Hip System - EXPRT Hip Distal Stem, EXPRT Hip Standard Offset Proximal Body Implant, EXPRT Hip Lateral Offset Proximal Body Implant, EXPRT Hip Capture Bolt
- K161610 — EXPRT Revision Hip System
More clearances from Exactech, Inc.
view allAdverse events under product code KWZ
product code KWZ- Injury
- 993
- Total
- 993
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 K071676
K-number listed on FDA's recall record- Z-0581-2024 — Exactech Novation Hip System, Catalog Numbers: 134-36-45
- Z-1730-2022 — GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071676.
Data sourced from openFDA. This site is unofficial and independent of the FDA.