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NOVASTEP

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30106737773010673777NOVASTEP1N2026-01-012 allee Jacques Frimot RENNES Bretagne FR 35000

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
03700879515540airlock® - Drill bit Ø3.6+33299338650regulatory-IntFA@enovis.com
03700879515687Airlock® - Spheric positionning pin+33299338650regulatory-IntFA@enovis.com
03700879517803airlock® - Upper tray+33299338650regulatory-IntFA@enovis.com
03700879518565PECAPLASTY® - Tray wires first+33299338650regulatory-IntFA@enovis.com
03700879518701NA - Zadek positioning template+33299338650regulatory-IntFA@enovis.com
03700879518718NA - Zadek Compression Guide+33299338650regulatory-IntFA@enovis.com
03700879518725NA - Zadek Hinge window Ø3+33299338650regulatory-IntFA@enovis.com
03700879518732NA - Zadek cutting window Ø3+33299338650regulatory-IntFA@enovis.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1784891335818096K260274Airlock® Ankle Plating SystemHRS2026-03-25
1784891868009791K230724arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesJDR2023-12-04
1784891327659808K223468Nexis® compressive screwsHWC2023-08-30
1784891824020473K192356Airlock Centrolock Osteosynthesis Implant SystemHRS2019-12-14
1784891185483514K151277Airlock® osteosynthesis plate systemHRS2015-08-13
1784891515005890K143523Airlock osteosynthesis plate systemHRS2015-04-06
1784891987911312K143229Nexis osteosynthesis compressive screwsHWC2015-02-06
1784891588714402K143146Nexis osteosynthesis snap-off screwsHWC2015-02-06
1784891242292771K143049LYNC intramedullary implantHTY2015-02-19
1784891349602967K142111ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLEJDR2014-12-19
1784891033671153
1784891697451374
1784891708225546
1784891579597826

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS72026-03-25
HWC52023-08-30
JDR32023-12-04
HTY22015-02-19

PMN#

GUDID#

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