FDA.report

NOVASTEP

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30106737773010673777NOVASTEP1N2026-01-012 allee Jacques Frimot RENNES Bretagne FR 35000
30113891643011389164Novastep Inc.1Y2020-04-2530 Ramland Road, Suite 200 Orangeburg NY US 10962

Registered Device Listings

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
1784891824020473K192356Airlock Centrolock Osteosynthesis Implant SystemHRS2019-12-14
1784891185483514K151277Airlock® osteosynthesis plate systemHRS2015-08-13
1784891185483514K151277Airlock® osteosynthesis plate systemHRS2015-08-13
1794592048379373K151277Airlock® osteosynthesis plate systemHRS2015-08-13
1784891515005890K143523Airlock osteosynthesis plate systemHRS2015-04-06
1784891515005890K143523Airlock osteosynthesis plate systemHRS2015-04-06
1794591814682193K143523Airlock osteosynthesis plate systemHRS2015-04-06
1794591615979984K143229Nexis osteosynthesis compressive screwsHWC2015-02-06
1784891987911312K143229Nexis osteosynthesis compressive screwsHWC2015-02-06
1784891987911312K143229Nexis osteosynthesis compressive screwsHWC2015-02-06
1794591422935278K143146Nexis osteosynthesis snap-off screwsHWC2015-02-06
1784891588714402K143146Nexis osteosynthesis snap-off screwsHWC2015-02-06
1784891588714402K143146Nexis osteosynthesis snap-off screwsHWC2015-02-06
1784891242292771K143049LYNC intramedullary implantHTY2015-02-19
1784891242292771K143049LYNC intramedullary implantHTY2015-02-19
1794592005551062K143049LYNC intramedullary implantHTY2015-02-19
1784891349602967K142111ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLEJDR2014-12-19
1784891349602967K142111ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLEJDR2014-12-19
1794591578254639K142111ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLEJDR2014-12-19
17848910336711531969-12-31
17848910336711531969-12-31
17848910336711531969-12-31
17848910336711531969-12-31
17945915880322111969-12-31
17945915880322111969-12-31
17945915880322111969-12-31
17945915880322111969-12-31
17848916974513741969-12-31
17848916974513741969-12-31
17848916974513741969-12-31
17848916974513741969-12-31
17848917082255461969-12-31
17848917082255461969-12-31
17848917082255461969-12-31
17848917082255461969-12-31
17945917895623151969-12-31
17945917895623151969-12-31
17945917895623151969-12-31
17945917895623151969-12-31
17945919622212931969-12-31
17945919622212931969-12-31
17945919622212931969-12-31
17945919622212931969-12-31
1784891033671153
1784891579597826
1784891697451374
1784891708225546

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
HRS92026-03-25
HWC72023-08-30
JDR42023-12-04
HTY32015-02-19

PMA

PMN

Applications

GUDID