Data / Medical devices / Italy / NCS Lab SRL
NCS Lab SRL: FDA-registered device maker in Carpi Modena, Italy, 3 510(k) clearances
NCS Lab SRL is registered with the FDA (registration 3011410128) in Carpi Modena, Italy. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 14, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011410128
- Address
- Via Pola Esterna 4/12, Carpi Modena, Italy, 41012
- Owner or operator
- NCS Lab Srl (10050099)
- Roles
- Manufacturer
- First device listed
- October 12, 2015
- Registered through
- 2026
- Brand names listed
- Compasso, Elite SPK, Elite SPK Kit, GT Tunneler, Shoulder Pacemaker TM, Showmotion, Taylor Stitcher Instrument with STN Needle
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Biofeedback | HCC | 2 | Manufacturer | accessdata.fda.gov |
| Exerciser, Measuring | ISD | 2 | Manufacturer | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Manufacturer | accessdata.fda.gov |
| Goniometer, Ac-Powered | KQX | 1 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| October 14, 2022 | K220994 | Shoulder PacemakerTM | IPF | Substantially Equivalent | Ncs Lab Srl | accessdata.fda.gov |
| August 24, 2021 | K210674 | Shoulder Pacemaker | IPF | Substantially Equivalent | Ncs Lab Srl | accessdata.fda.gov |
| April 20, 2016 | K160500 | Elite SPK, Compasso, Elite SPK Kit | MBI | Substantially Equivalent | Ncs Lab Srl | accessdata.fda.gov |
Compare with other makers
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Stimulator, Muscle, Powered
- All makers of Goniometer, Ac-Powered
- All makers of Exerciser, Measuring
- All makers of Device, Biofeedback
- All makers of Orthopedic Manual Surgical Instrument
Updated October 14, 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.