Spintech, Inc.
Bingham Farms, MI, US
SPINTECH, INC. appears in FDA device records in Bingham Farms, MI. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Spintech, Inc. between 1992 and 2022. The busiest year on record is 2021, with 3. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1996 | 2 |
| 2000 | 2 |
| 2001 | 1 |
| 2003 | 1 |
| 2018 | 1 |
| 2021 | 3 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223079 | Stage | LNH | Substantially Equivalent | |
| K212109 | Spin Care Disposable Protective Mask Level 3 | FXX | Substantially Equivalent | |
| K210843 | STAGE | LNH | Substantially Equivalent | |
| K201624 | Spin Care Disposable Protective Mask | FXX | Substantially Equivalent | |
| K173224 | SPIN-SWI | LNH | Substantially Equivalent | |
| K023722 | SAFETYWAND DISPOSABLE HANDPIECE | EJI | Substantially Equivalent | |
| K010692 | THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM | FMF | Substantially Equivalent | |
| K992404 | THE WAND | FMF | Substantially Equivalent | |
| K992819 | WAND PLUS | EJI | Substantially Equivalent | |
| K961648 | THE WAND | EJI | Substantially Equivalent | |
| K955654 | SHORTSTOP DISPOSABLE PROPHY ANGLE | EFB | Substantially Equivalent | |
| K922238 | LEAPLAZA FRAME | KWP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3020162557 | 3020162557 | SPINTECH, INC. | 30200 Telegraph Road, Bingham Farms, MI 48025 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain