# Spintech, Inc.

- Location (FDA's records): Washington, DC
- FDA decisions: 12 (1992–2022): 12 510(k) clearances
- Names in FDA's records: Spintech, Inc. (10); Spintech, LLC (2)
- Product codes: LNH (3), EJI (3), FMF (2), FXX (2), KWP (1), EFB (1)
- 510(k) review time since 2016: median 131 days, against 128 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 12 (4 its own); citations of its devices by later devices: 6 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Philips Medical Systems Nederland B.V.: 1 (https://510kreport.com/company/philips-medical-systems-nederland)
- International Regulatory Consultants: 1 (https://510kreport.com/company/international-regulatory-consultants)
- Dentsply Midwest: 1 (https://510kreport.com/company/dentsply-midwest)
- Syntheticmr AB: 1 (https://510kreport.com/company/syntheticmr)
- Integritech, Inc.: 1 (https://510kreport.com/company/integritech)
- Xiantao Rayxin Medical Products Co., Ltd.: 1 (https://510kreport.com/company/xiantao-rayxin-medical-products)
- San-M Package Co., Ltd.: 1 (https://510kreport.com/company/san-m-package)
- Freudenberg Performance Materials LP: 1 (https://510kreport.com/company/freudenberg-performance-materials)

## Firms that cite its devices most
- Dentsply Midwest: 1 (https://510kreport.com/company/dentsply-midwest)
- Heuron Co., Ltd.: 1 (https://510kreport.com/company/heuron)

## Its most-cited devices
- K173224: Spin-Swi (2018), cited by 2
- K961648: The Wand (1996), cited by 2
- K992819: Wand Plus (2000), cited by 1
- K210843: STAGE (2021), cited by 1

## Recent decisions
- K223079: Stage (Oct 28, 2022)
- K212109: Spin Care Disposable Protective Mask Level 3 (Nov 14, 2021)
- K210843: STAGE (Jun 29, 2021)
- K201624: Spin Care Disposable Protective Mask (Mar 18, 2021)
- K173224: Spin-Swi (Feb 23, 2018)
- K023722: Safetywand Disposable Handpiece (Sep 2, 2003)
- K010692: The Wand Plus Computer Controlled Anesthetic Delivery System (Jun 29, 2001)
- K992404: The Wand (Jun 6, 2000)

Source page: https://510kreport.com/company/spintech