DeviceClearance

SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM— 510(k) K994128

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K994128 for SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM, Substantially Equivalent on 2000-03-06. Applicant: Howmedica Osteonics Corp.. Device class: 2.

Clearance details

Applicant
Howmedica 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
Clearance type
Traditional
Location
Allendale, NJ, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code JWH

view all

More clearances from Howmedica Osteonics Corp.

view all

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 K994128

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 K994128.

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