FDA.reportPublic FDA data

ADDITIVE IMPLANTS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30139615793013961579ADDITIVE IMPLANTS1N2026-01-013101 E Shea Blvd Ste 122 Phoenix AZ US 85028
30139615793013961579ADDITIVE IMPLANTS1N2020-04-253101 East Shea Boulevard Suite 122 Phoenix AZ US 85028

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
00817662020648SureMAX - SureMAX Cervical Spacer, 0° Parallel Large (15mm x 18mm) x 5mm6027958850quality@additiveimplant.com
00817662020655SureMAX - SureMAX Cervical Spacer, 0° Parallel Large (15mm x 18mm) x 6mm6027958850quality@additiveimplant.com
00817662020662SureMAX - SureMAX Cervical Spacer, 0° Parallel Large (15mm x 18mm) x 7mm6027958850quality@additiveimplant.com
00817662020679SureMAX - SureMAX Cervical Spacer, 0° Parallel Large (15mm x 18mm) x 8mm6027958850quality@additiveimplant.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3133411405499976K211111SureMAX-SA Cervical Standalone SystemOVE2021-07-16
2271521202834441K193359SureMAX Family of Cervical SpacersODP2020-01-03
3133411202834441K193359SureMAX Family of Cervical SpacersODP2020-01-03
2271521173059165K182477Cervical SpacerODP2019-01-28
3133411173059165K182477Cervical SpacerODP2019-01-28

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
ODP42020-01-03
OVE12021-07-16

PMN#

GUDID#

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