STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)— 510(k) K040300
Substantially EquivalentStryker Instruments
FDA 510(k) clearance K040300 for STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE), Substantially Equivalent on 2004-03-03. Applicant: Stryker Instruments. Device class: 2.
Clearance details
- Applicant
- Stryker Instruments
- Product code
- Code ERL
- Device class
- Class 2
- Regulation
- 21 CFR 874.4250
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kalamazoo, MI, US
Recent devices under product code ERL
view allMore clearances from Stryker Instruments
view allAdverse events under product code ERL
product code ERL- Malfunction
- 11,234
- Total
- 11,234
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 K040300
K-number listed on FDA's recall record- Z-1740-2013 — Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.
- Z-1741-2013 — CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performance System (TPS) is intended for usein the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.
- Z-1742-2013 — RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (CORE TM) System. When used with a variety of accessories, the RemB Electric Universal Driver is intended for surgical procedures involving driving wire or pins into bone and hard tissue. This includes but is not limited to Dental, ENT (Ear, Nose, Throat), Neuro, and Endoscopic applications. This device can also be used with the Total Performance System (TPSTM).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040300.
Data sourced from openFDA. This site is unofficial and independent of the FDA.