SCHULTZ PHALANGEAL COMPONENT DRIVER— 510(k) K870847

Name: FDA 510(k) clearance K870847
Creator: U.S. Food and Drug Administration
Published: 1987-03-13

Substantially Equivalent

Warsaw Orthopedic, Inc.

FDA 510(k) clearance K870847 for SCHULTZ PHALANGEAL COMPONENT DRIVER, Substantially Equivalent on 1987-03-13. Applicant: Warsaw Orthopedic, Inc.. Device class: 1.

Clearance details

Applicant: Warsaw Orthopedic, Inc.
Product code: Code HWR
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1987-03-03
Decision date: 1987-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HWR

view all

K915776 — KNEE PROSTHESIS DRIVER1992-06-11
K875054 — ACROMED ADS BONE NAIL DRIVER1988-01-28
K870848 — SCHULTZ METACARPAL COMPONENT DRIVER1987-03-13

More clearances from Warsaw Orthopedic, Inc.

view all

K892877 — CRADLE, HOSPITAL BED CLOTHING1989-06-15
K883783 — TSRH SACRAL SPINAL SCREW1989-04-06
K883784 — TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE1989-04-06
K880211 — TSRH H/M HOOK HOLDER1988-03-04
K880212 — TSRH H/M HOOK HOLDER W/ROD MOVER1988-03-04

Adverse events under product code HWR

product code HWR

Malfunction: 6,549
Total: 6,549

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.