Data / Medical devices / United States / Maxmorespine
Maxmorespine: FDA-registered device maker in San Diego, CA, United States, 7 510(k) clearances
Maxmorespine is registered with the FDA (registration 3023155873) in San Diego, CA, United States. 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
- 3023155873
- Address
- 8659 Production Ave. Suite A, San Diego, CA, United States, 92121
- Owner or operator
- Maxmorespine (10086790)
- Roles
- Complaint file establishment
- First device listed
- December 12, 2022
- Registered through
- 2026
- Brand names listed
- BD Quincke Spinal Needle, Needle Placer, Tactile Ball Hook - 400mm, 2.5mm, maxmore Smart Pack System
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.