OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS— 510(k) K950652

Name: FDA 510(k) clearance K950652
Creator: U.S. Food and Drug Administration
Published: 1995-06-22

Substantially Equivalent for Some Indications

Osteotech, Inc.

FDA 510(k) clearance K950652 for OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS, Substantially Equivalent for Some Indications on 1995-06-22. Applicant: Osteotech, Inc.. Device class: 2.

Clearance details

Applicant: Osteotech, Inc.
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1995-02-13
Decision date: 1995-06-22
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Shrewsbury, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HWC

view all

K261057 — ActivaScrew Cannulated COM2026-09-04
K260106 — OsteoCoil GT Active Compression System2026-08-24
K262344 — Large Compression Screws2026-08-12
K253858 — GFS - Sterile Screws and Top Hat2026-08-05
K262075 — Lapidus Screw Kit2026-07-22

More clearances from Osteotech, Inc.

view all

K082615 — GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES2008-10-16
K081227 — PLEXUR M2008-07-22
K080511 — PLEXUR-P2008-04-21
K073405 — PLEXUR M2008-03-03
K061982 — PLEXUR P2007-02-07

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.