DeviceClearance

OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT; OSTEONICS SCORPIO TOTAL KNEE RECESSED PATELLAR COMPONENT— 510(k) K972967

Substantially Equivalent for Some Indications

Osteonics Corp.

FDA 510(k) clearance K972967 for OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT; OSTEONICS SCORPIO TOTAL KNEE RECESSED PATELLAR COMPONENT, Substantially Equivalent for Some Indications on 1998-01-16. Applicant: Osteonics Corp.. Device class: 2.

Clearance details

Device name as filed
OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT;OSTEONICS SCORPIO TOTAL KNEE RECESSED PATELLAR COMPONENT
Applicant
Osteonics Corp.
Product code
Code JWH
Device class
Class 2
Regulation
21 CFR 888.3560
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent for Some Indications
Clearance type
Traditional
Location
Allendale, NJ, US
Download summary PDFView on FDA.gov ↗

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More clearances from Osteonics Corp.

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Adverse events under product code JWH

product code JWH
Death
26
Injury
51,564
Malfunction
9,725
Other
9
Total
61,324

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 K972967

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K972967.

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