CONFIDENCE HIGH VISCOSITY BONE CEMENT— 510(k) K060300

Clearance details

Applicant

Disc-O-Tech Medical Technologies, Ltd.

Product code

Code NDN

Device class

Class 2

Regulation

21 CFR 888.3027

Advisory panel

Orthopedic

Date received

2006-02-06

Decision date

2006-06-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Herzliya, IL

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• K232842 — Balloon Inflation System2024-02-29

• K071375 — MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)2007-12-21
• K071679 — METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS2007-12-17
• K063067 — CONFIDENCE FENESTRATED INTRODUCER NEEDLE2006-11-03
• K062424 — CONFIDENCE EX HIGH VISCOSITY BONE CEMENT2006-09-14
• K040612 — SKY BONE EXPANDER SYSTEM (SKY SYSTEM)2004-06-17

Death

24

Injury

407

Malfunction

1,975

Total

2,406

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 →

• Z-1300-2018 — Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL CEMENT SYSTEM¿ 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).Class II·Terminated·DePuy Spine, Inc.·20171215
• Z-2132-2013 — CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.Class II·Terminated·DePuy Spine, Inc.·20130417
• Z-2133-2013 — CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty proceduresClass II·Terminated·DePuy Spine, Inc.·20130417
• Z-2134-2013 — CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.Class II·Terminated·DePuy Spine, Inc.·20130417
• Z-0960-2013 — DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.Class II·Terminated·DePuy Spine, Inc.·20130115
• Z-0961-2013 — DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.Class II·Terminated·DePuy Spine, Inc.·20130115
• Z-0962-2013 — DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.Class II·Terminated·DePuy Spine, Inc.·20130115
• Z-0963-2013 — DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.Class II·Terminated·DePuy Spine, Inc.·20130115

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060300.