THREADED FIXATION PIN— 510(k) K963433

Name: FDA 510(k) clearance K963433
Creator: U.S. Food and Drug Administration
Published: 1996-11-06

Substantially Equivalent

Orthopaedic Biosystems, Ltd.

FDA 510(k) clearance K963433 for THREADED FIXATION PIN, Substantially Equivalent on 1996-11-06. Applicant: Orthopaedic Biosystems, Ltd.. Device class: 2.

Clearance details

Applicant: Orthopaedic Biosystems, Ltd.
Product code: Code JDW
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1996-08-30
Decision date: 1996-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scotsdale, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDW

view all

K260073 — XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm2026-02-10
K250316 — Meduloc Intramedullary Fracture Fixation (IFF) System2025-10-29
K241357 — XT3 System2025-01-22
K223112 — MAVERICK Mini External Fixation System2022-12-08
K213874 — MAVERICK External Fixation System2022-02-11

More clearances from Orthopaedic Biosystems, Ltd.

view all

K000797 — OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-012000-04-03
K982996 — POLYMER OBL SB ANCHOR / SUTURE COMBINATION1999-03-04
K983169 — POLYMER THREADED ANCHOR1998-12-16
K982963 — POLYMER THREADED ANCHOR / SUTURE COMBINATION1998-11-20
K972326 — PEBA ANCHOR/SUTURE COMBINATION1998-02-06

Adverse events under product code JDW

product code JDW

Injury: 717
Total: 717

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.