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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K213935

PISCES-SA Standalone ALIF Interbody System · Osseus Fusion Systems · decided 2022-05-06 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Pisces-SA1700-L112SOsseus Fusion Systems, LLCMAX OVD PHMB0621700L112
Pisces-SA1750-L116Osseus Fusion Systems, LLCFZXB0621750L116
Pisces-SA1720-5038Osseus Fusion Systems, LLCOVDB06217205038
Pisces-SA1750-0001Osseus Fusion Systems, LLCMAX OVD PHMB06217500001
Pisces-SA1700-S136SOsseus Fusion Systems, LLCMAX OVD PHMB0621700S136
Pisces-SA1760-7049Osseus Fusion Systems, LLCHTXB06217607049
Pisces-SA1760-7030Osseus Fusion Systems, LLCFZSB06217607030
Pisces-SA1760-7096Osseus Fusion Systems, LLCLXHB06217607096
Pisces-SA1700-M152SOsseus Fusion Systems, LLCMAX OVD PHMB0621700M152
Pisces-SA1700-L098SOsseus Fusion Systems, LLCMAX OVD PHMB0621700L098
Pisces-SA1760-7103Osseus Fusion Systems, LLCHWMB06217607103
Pisces-SA1760-7012Osseus Fusion Systems, LLCFZSB06217607012
Pisces-SA1750-S192Osseus Fusion Systems, LLCFZXB0621750S192
Pisces-SA1750-M156Osseus Fusion Systems, LLCFZXB0621750M156
Pisces-SA1700-S178Osseus Fusion Systems, LLCMAX OVD PHMB0621700S178
Pisces-SA1750-0054Osseus Fusion Systems, LLCHWXB06217500054
Pisces-SA1760-7073Osseus Fusion Systems, LLCHTXB06217607073
Pisces-SA1750-S116Osseus Fusion Systems, LLCFZXB0621750S116
Pisces-SA1760-7043Osseus Fusion Systems, LLCHTXB06217607043
Pisces-SA1760-7003Osseus Fusion Systems, LLCGEGB06217607003
Pisces-SA1720-5133Osseus Fusion Systems, LLCOVDB06217205133
Pisces-SA1700-L130SOsseus Fusion Systems, LLCMAX OVD PHMB0621700L130
Pisces-SA1760-7079Osseus Fusion Systems, LLCHTXB06217607079
Pisces-SA1750-0016Osseus Fusion Systems, LLCLXHB06217500016
Pisces-SA1720-0001Osseus Fusion Systems, LLCOVDB06217200001