Data / Medical devices / Germany / Hoogland Spine Products GmbH
Hoogland Spine Products GmbH: FDA-registered device maker in Unterfoehring Munich Bavaria, Germany, 7 510(k) clearances
Hoogland Spine Products GmbH is registered with the FDA (registration 3006561161) in Unterfoehring Munich Bavaria, Germany. It lists 33 device types. The FDA files 7 510(k) clearances under its listings, the newest dated June 23, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006561161
- Address
- Feringastr. 4, Unterfoehring Munich Bavaria, Germany, 85774
- Owner or operator
- Hoogland Spine Products GmbH (10023561)
- Roles
- Exporter to the US, Specification developer
- First device listed
- December 3, 2007
- Registered through
- 2026
- Brand names listed
- BD Quincke Spinal Needle, Container small 1/2, MaxMore TOM painless hammer, MaxMoreSpine TOM Stick, Needle Placer, Sterile Spinal Needle - 18G, maxMore TOM Stick Endoscope, maxMore TOMshidi needle and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 23, 2022 | K211173 | maxmorespine Bipolar Electrodes | GEI | Substantially Equivalent | Hoogland Spine Products, GmbH | accessdata.fda.gov |
| December 22, 2021 | K210978 | BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle | BSP | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| September 29, 2020 | K193131 | BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle | BSP | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| April 16, 2012 | K120117 | CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM | KCT | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| October 9, 2009 | K083552 | MAXMORESPINE TOM STICK | HRX | Substantially Equivalent | Hoogland Spine Products, GmbH | accessdata.fda.gov |
| June 9, 2009 | K090132 | MAXMORESPINE SPINAL SYSTEM | HRX | Substantially Equivalent | Hoogland Spine Products, GmbH | accessdata.fda.gov |
| January 20, 1987 | K864402 | BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBE | GEI | Substantially Equivalent | New England Surgical Instrument Corp. | accessdata.fda.gov |
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Updated June 23, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.