Pisces-SA 1720-5015

GUDID B06217205015

Bone Screw, Variable, Self-Tapping, 15mm, PISCES-SA

Osseus Fusion Systems, LLC

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device IDB06217205015
NIH Device Record Key584ddbc3-dc7f-448e-a5dc-0864d2b8fc9c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePisces-SA
Version Model Number1720-5015
Catalog Number1720-5015
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB06217205015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B06217205015]

Moist Heat or Steam Sterilization


[B06217205015]

Moist Heat or Steam Sterilization


[B06217205015]

Moist Heat or Steam Sterilization


[B06217205015]

Moist Heat or Steam Sterilization


[B06217205015]

Moist Heat or Steam Sterilization


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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