510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SAIClass II

Ankle Fusion Cage

21 CFR 888.3020 / Orthopedic
FDA source (opens on fda.gov)

SAI is the FDA product code for Ankle Fusion Cage, a class II device type, regulated under 21 CFR 888.3020. FDA's definition for this code reads: "Intended for use as an accessory to a tibiotalocalcaneal Intramedullary (IM) rod as part of a fusion construct for failed ankle arthrodesis or failed ankle arthroplasty. Not intended for standalone use". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SAI
Device name
Ankle Fusion Cage
FDA definition
Intended for use as an accessory to a tibiotalocalcaneal Intramedullary (IM) rod as part of a fusion construct for failed ankle arthrodesis or failed ankle arthroplasty. Not intended for standalone use.
Regulation
21 CFR 888.3020
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code SAI

By decision year
2 clearances under product code SAI with a decision year between 2024 and 2025, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SAI by decision year
YearClearances
20241
20251

Applicants with the most clearances

Product code SAI
Applicants holding the most 510(k) clearances under product code SAI
ApplicantClearances
4Web Medical, Inc.1
restor3d, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code