FDA.reportPublic FDA data

HAPPE SPINE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30277263673027726367HAPPE SPINE1N2026-01-012851 Charlevoix Dr. SE Suite 327 Grand Rapids MI US 49546

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
G2308H1FT13M100INTEGRATE-C - Single End Trial - Medium 17x14x13mm 10deg616-984-0204xxxx@xx.xx
G2308H1FT13S100INTEGRATE-C - Single End Trial - Small 15x12x13mm 10deg616-984-0204xxxx@xx.xx
G2308H1FT14L100INTEGRATE-C - Single End Trial - Large 20x15x14mm 10deg616-984-0204xxxx@xx.xx
G2308H1FT14M100INTEGRATE-C - Single End Trial - Medium 17x14x14mm 10deg616-984-0204xxxx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3195021723884255K222004INTEGRATE -C Interbody Fusion SystemODP2023-04-28
3195021979618973

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
ODP12023-04-28

PMN#

GUDID#

80 records. Showing 1-40. Next