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SPINEWAY

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30107586863010758686SPINEWAY1N2020-04-257 Allee Moulin Berger Ecully Rhone-Alpes FR 69130
30131479463013147946SPINEWAY USA, Inc.1Y2020-04-2513100 Wayzata Blvd Suite 110 Minnetonka MN US 55305

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
03663422000118Mont Blanc Spinal Systems - LAMINAR THORACIC HOOK+33472770152info@spineway.com
03663422000699Mont Blanc Spinal Systems - PEDICLE HOOK+33472770152info@spineway.com
03663422002020Mont Blanc Spinal Systems - TRANSVERSE HOOK+33472770152info@spineway.com
03663422500076MONT BLANC - Container, deformity+33472770152info@spineway.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1851252071532275K191726mont blanc & mont blanc MIS Spinal SystemsNKB2019-09-12
1851251052802095K162694Ayers Rock Cervical interbody fusion systemODP2017-01-12
1851251642439445K161387Mont Blanc and Mont Blanc MIS Spinal SystemsNKB2016-08-04
1851251869015392K152355Twin Peaks Lumbar Interbody Fusion SystemMAX2015-12-10
1851251827978295K150036Blue Mountain Cervical Plate SystemKWQ2015-05-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB22019-09-12
ODP12017-01-12
MAX12015-12-10
KWQ12015-05-07

PMN#

GUDID#

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