Pisces-SA 1700-S110S

GUDID B0621700S110

23x29x11, 20°, Sterile, Standalone ALIF Interbody, PISCES-SA

Osseus Fusion Systems, LLC

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage
Primary Device IDB0621700S110
NIH Device Record Key17075150-d0cc-4c24-ae09-613726f2ae04
Commercial Distribution StatusIn Commercial Distribution
Brand NamePisces-SA
Version Model Number1700-S110S
Catalog Number1700-S110S
Company DUNS933442068
Company NameOsseus Fusion Systems, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB0621700S110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-26
Device Publish Date2022-05-18

On-Brand Devices [Pisces-SA]

B0621790000720° Trial Module, PISCES™-SA
B0621790000616° Trial Module, PISCES™-SA
B0621790000512° Trial Module, PISCES™-SA
B0621752L17029x39x17, 20°, Trial, PISCES-SA
B0621750S19823x29x19, 8°, Trial, PISCES-SA
B0621750S19623x29x19, 16°, Trial, PISCES-SA
B0621750S19223x29x19, 12°, Trial, PISCES-SA
B0621750S19023x29x19, 20°, Trial, PISCES-SA
B0621750S17823x29x17, 8°, Trial, PISCES-SA
B0621750S17623x29x17, 16°, Trial, PISCES-SA
B0621750S17223x29x17, 12°, Trial, PISCES-SA
B0621750S17023x29x17, 20°, Trial, PISCES-SA
B0621750S15823x29x15, 8°, Trial, PISCES-SA
B0621750S15623x29x15, 16°, Trial, PISCES-SA
B0621750S15223x29x15, 12°, Trial, PISCES-SA
B0621750S15023x29x15, 20°, Trial, PISCES-SA
B0621750S13823x29x13, 8°, Trial, PISCES-SA
B0621750S13623x29x13, 16°, Trial, PISCES-SA
B0621750S13223x29x13, 12°, Trial, PISCES-SA
B0621750S13023x29x13, 20°, Trial, PISCES-SA
B0621750S11823x29x11, 8°, Trial, PISCES-SA
B0621750S11623x29x11, 16°, Trial, PISCES-SA
B0621750S11223x29x11, 12°, Trial, PISCES-SA
B0621750S11023x29x11, 20°, Trial, PISCES-SA
B0621750S09823x29x09, 8°, Trial, PISCES-SA
B0621750S09623x29x09, 16°, Trial, PISCES-SA
B0621750S09223x29x09, 12°, Trial, PISCES-SA
B0621750S07823x29x07, 8°, Trial, PISCES-SA
B0621750S07623x29x07, 16°, Trial, PISCES-SA
B0621750S07223x29x07, 12°, Trial, PISCES-SA
B0621750M19826x35x19, 8°, Trial, PISCES-SA
B0621750M19626x35x19, 16°, Trial, PISCES-SA
B0621750M19226x35x19, 12°, Trial, PISCES-SA
B0621750M19026x35x19, 20°, Trial, PISCES-SA
B0621750M17826x35x17, 8°, Trial, PISCES-SA
B0621750M17626x35x17, 16°, Trial, PISCES-SA
B0621750M17226x35x17, 12°, Trial, PISCES-SA
B0621750M17026x35x17, 20°, Trial, PISCES-SA
B0621750M15826x35x15, 8°, Trial, PISCES-SA
B0621750M15626x35x15, 16°, Trial, PISCES-SA
B0621750M15226x35x15, 12°, Trial, PISCES-SA
B0621750M15026x35x15, 20°, Trial, PISCES-SA
B0621750M13826x35x13, 8°, Trial, PISCES-SA
B0621750M13626x35x13, 16°, Trial, PISCES-SA
B0621750M13226x35x13, 12°, Trial, PISCES-SA
B0621750M13026x35x13, 20°, Trial, PISCES-SA
B0621750M11826x35x11, 8°, Trial, PISCES-SA
B0621750M11626x35x11, 16°, Trial, PISCES-SA
B0621750M11226x35x11, 12°, Trial, PISCES-SA
B0621750M11026x35x11, 20°, Trial, PISCES-SA

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