Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1059911211
Device Listing 1059911211
Listing Summary
#
Listing key
1059911211
Premarket submission
K243816
Device
Testa TP Pivoting Spacer System
Applicant
Spine Wave, Inc.
Product code
MAX
Decision date
2025-06-27
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
61685
3004638600
3004638600
SPINE WAVE, INC.
1
N
2026-01-01
THREE ENTERPRISE DR. SUITE 210 SHELTON CT US 06484