CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM— 510(k) K021549

Name: FDA 510(k) clearance K021549
Creator: U.S. Food and Drug Administration
Published: 2002-08-01

Substantially Equivalent

Std Mfg., Inc.

FDA 510(k) clearance K021549 for CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM, Substantially Equivalent on 2002-08-01. Applicant: Std Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Std Mfg., Inc.
Product code: Code KXA
Device class: Class 2
Regulation: 21 CFR 888.3400
Advisory panel: Orthopedic
Date received: 2002-05-13
Decision date: 2002-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stoughton, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KXA

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K201219 — Biocore9 Femoral Head Resurfacing Component2021-01-19
K092198 — CORMET CEMENTLESS RESURFACING FEMORAL HEAD2010-04-15
K082673 — CONSERVE PRESSFIT FEMORAL COMPONENT2008-12-12
K071053 — RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD2007-06-29
K070292 — DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS2007-04-26

More clearances from Std Mfg., Inc.

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K023096 — CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM2003-04-10
K012362 — MODIFICATION TO VASCULAR CLOSURE DEVICE2001-08-23
K003169 — VASCULAR CLOSURE DEVICE2000-12-08
K000608 — SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM2000-03-07
K930427 — STD IRRIGATION PUMP1993-06-01

Adverse events under product code KXA

product code KXA

Injury: 324
Total: 324

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.