FIXATION INSTRUMENTS— 510(k) K863727

Name: FDA 510(k) clearance K863727
Creator: U.S. Food and Drug Administration
Published: 1986-10-31

Substantially Equivalent

Medical Technology Development Corp.

FDA 510(k) clearance K863727 for FIXATION INSTRUMENTS, Substantially Equivalent on 1986-10-31. Applicant: Medical Technology Development Corp.. Device class: 1.

Clearance details

Applicant: Medical Technology Development Corp.
Product code: Code HNR
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1986-09-23
Decision date: 1986-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Medical Technology Development Corp.

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K941488 — DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER1994-11-30
K862315 — FYODOROV COLLAGEN CORNEAL SHIELD1987-01-07
K863725 — CATARACT DIAMOND KNIFE1986-10-31
K863726 — INSTRUMENT STERILIZATION TRAY1986-10-14

Adverse events under product code HNR

product code HNR

Malfunction: 497
Other: 1
Total: 498

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.