Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments— 510(k) K143320
Substantially EquivalentStryker Corp.
FDA 510(k) clearance K143320 for Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments, Substantially Equivalent on 2015-04-23. Applicant: Stryker Corp.. Device class: 2.
Clearance details
- Applicant
- Stryker Corp.
- Product code
- Code HBE
- Device class
- Class 2
- Regulation
- 21 CFR 882.4310
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kalamazoo, MI, US
Recent devices under product code HBE
view allMore clearances from Stryker Corp.
view allAdverse events under product code HBE
product code HBE- Injury
- 306
- Malfunction
- 7,175
- Other
- 1
- Total
- 7,482
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K143320
K-number listed on FDA's recall record- Z-0063-2025 — 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not limited to dental, ENT (ear, nose and throat), neuro, spine and endoscopic applications Catalog Number: 5820-066-012
- Z-0980-2025 — The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/ Otorhinolaryngology, orthopedic, and general surgical applications including maxillofacial and craniofacial surgeries. The 3.0MM Prec Neuro Match Head bur (5820-107-530) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/Otorhinolaryngology, orthopedic, and general surgical applications including maxillofacial and craniofacial surgeries. These burs are sold as single use devices without their own IFU.
- Z-0981-2025 — stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
- Z-0982-2025 — stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery
- Z-1478-2022 — Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
- Z-2204-2016 — 5.0mm Round Fluted Bur, Super Long
- Z-2205-2016 — 6.0mm Round Fluted Bur, Super Long
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143320.
Data sourced from openFDA. This site is unofficial and independent of the FDA.