KIRSCHNER BLADE PLATE SYSTEM OR R.A.B. BLADE PLATE— 510(k) K901234

Clearance details

Applicant

Kirschner Medical Corp.

Product code

Code KTT

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

1990-03-14

Decision date

1990-10-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Timonium, MD, US

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• K940537 — KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM1995-08-29
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• K933843 — LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATED1994-08-05

Death

11

Injury

3,097

Malfunction

1,261

Total

4,369

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 →