Home › Device types › HBW
Fastener, Plate, Cranioplasty
FDA product code HBW · Class 2 · Neurology
1,291
Registered devices
82
Adverse events
1
Recalls
7
510(k) clearances
Devices with this code
Neuro Plating System — OSTEONIC CO.,Ltd.UNIVERSAL NEURO 3 — Stryker Leibinger GmbH & Co. KG"1MM" SYSTEM PLATE — BIOMET MICROFIXATION, INCDELTA — Stryker Leibinger GmbH & Co. KGLeforte Neuro System Bone Plate — Jeil Medical Corporation1.5MM SYSTEM — BIOMET MICROFIXATION, INCUniversal Neuro 3 — Stryker Leibinger GmbH & Co. KG"2.0MM" SYSTEM — BIOMET MICROFIXATION, INCLeforte Neuro System Bone Plate — Jeil Medical Corporation1.5MM SYSTEM — BIOMET MICROFIXATION, INCNeuroPro® Low Profile — Kinamed, Inc.1.5MM SYSTEM — BIOMET MICROFIXATION, INC1.5MM SYSTEM — BIOMET MICROFIXATION, INC1.5MM SYSTEM — BIOMET MICROFIXATION, INCLeforte Neuro System Bone Plate — Jeil Medical Corporation2.0MM SYSTEM — BIOMET MICROFIXATION, INC1.5MM SYSTEM — BIOMET MICROFIXATION, INCInnovasis® Cranial System — INNO Holdings, Inc.Leforte Neuro System Bone Screw — Jeil Medical CorporationDELTA — Stryker Leibinger GmbH & Co. KGInnovasis® Cranial System — INNO Holdings, Inc.THINFLAP SYSTEM — BIOMET MICROFIXATION, INC1.5MM SYSTEM — BIOMET MICROFIXATION, INCLeforte Neuro System Bone Plate — Jeil Medical Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-24 | Synthes (USA) Products LLC | Products not sterilized, sterility cannot be confirmed |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.