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Company-Registration
1375106784
Device Listing 1375106784
Listing Summary
#
Listing key
1375106784
Premarket submission
K251690
Device
Arthrex SpeedFLEX™ Implant
Applicant
Arthrex, Inc.
Product code
OWY
Decision date
2025-09-30
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
1476
1220246
1220246
ARTHREX, INC.
1
N
2026-01-01
1370 Creekside Blvd Naples FL US 34108
159366
3010331645
3010331645
Arthrex, Inc.
1
N
2026-01-01
6875 Arthrex Commerce Drive Ave Maria FL US 34142
233362
3015231789
3015231789
Arthrex Manufacturing Inc.
1
N
2026-01-01
130 Arthrex Drive Pendleton SC US 29670