AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT— 510(k) K902259

Name: FDA 510(k) clearance K902259
Creator: U.S. Food and Drug Administration
Published: 1990-06-18

Substantially Equivalent for Some Indications

Orthomet, Inc.

FDA 510(k) clearance K902259 for AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT, Substantially Equivalent for Some Indications on 1990-06-18. Applicant: Orthomet, Inc.. Device class: 1.

Clearance details

Applicant: Orthomet, Inc.
Product code: Code JWX
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1990-05-21
Decision date: 1990-06-18
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWX

view all

K090964 — BINAXNOX STAPHYLOCOCCUS AUREUS TEST2009-12-16
K972030 — STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS1997-09-08
K964315 — REMEL STAPH LATEX KIT1997-02-07
K945538 — STAPHAUREX PLUS(TM)1995-06-01
K926173 — STAPH-A-LEX(TM) SYSTEM1993-08-10

More clearances from Orthomet, Inc.

view all

K936310 — ORTHOMET HMC FEMORAL STEM COMPONENT1995-06-07
K945783 — ORTHOMET TITANIUM HYBRID FEMORAL STEM1995-05-30
K943873 — ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY1995-04-26
K944752 — ORTHOMET RESURFACING FEMORAL COMPONENT1994-12-28
K930771 — PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM1994-11-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.