BONE SCREW— 510(k) K893203

Name: FDA 510(k) clearance K893203
Creator: U.S. Food and Drug Administration
Published: 1990-04-04

Substantially Equivalent

Karlin Technology, Inc.

FDA 510(k) clearance K893203 for BONE SCREW, Substantially Equivalent on 1990-04-04. Applicant: Karlin Technology, Inc.. Device class: 2.

Clearance details

Applicant: Karlin Technology, Inc.
Product code: Code JDR
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1989-04-26
Decision date: 1990-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrance, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Karlin Technology, Inc.

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K903969 — SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET1990-09-05
K893201 — BONE PLATE1990-04-04
K882525 — SPINAL MICROKNIFE1988-09-22
K882519 — X-RAY MARKER1988-08-09
K882073 — SPINAL NEEDLE1988-07-18

Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.