FDA.reportPublic FDA data

Pisces-SA

Primary DI
B0621700S112
Brand
Pisces-SA
Company
Osseus Fusion Systems, LLC
Model
1700-S112S
Catalog number
1700-S112S
Device description
23x29x11, 12°, Sterile, Standalone ALIF Interbody, PISCES-SA
Published
2022-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
PHMIntervertebral Fusion Device With Bone Graft, Thoracic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2
PHMIntervertebral Fusion Device With Bone Graft, ThoracicOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213935000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213935000PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems2022-05-06OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0621700S112PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
933442068
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B06224200000Black Diamond POCT2420-00002420-00002023-06-14
B06224200001Black Diamond POCT2420-00012420-00012023-06-14
B06224200002Black Diamond POCT2420-00022420-00022023-06-14
B06211000524Aries-TS TSLIF Lumbar Interbody System1100-0524S1100-0524S2022-11-07
B06211000525Aries-TS TSLIF Lumbar Interbody System1100-0525S1100-0525S2022-11-07
B06211000526Aries-TS TSLIF Lumbar Interbody System1100-0526S1100-0526S2022-11-07
B06211000527Aries-TS TSLIF Lumbar Interbody System1100-0527S1100-0527S2022-11-07
B06211000528Aries-TS TSLIF Lumbar Interbody System1100-0528S1100-0528S2022-11-07
B06211000529Aries-TS TSLIF Lumbar Interbody System1100-0529S1100-0529S2022-11-07
B06211000126Aries-TS TSLIF Lumbar Interbody System1100-0126S1100-0126S2022-11-04
B06211000127Aries-TS TSLIF Lumbar Interbody System1100-0127S1100-0127S2022-11-04
B06211000128Aries-TS TSLIF Lumbar Interbody System1100-0128S1100-0128S2022-11-04
B06211000129Aries-TS TSLIF Lumbar Interbody System1100-0129S1100-0129S2022-11-04
B06211000326Aries-TS TSLIF Lumbar Interbody System1100-0326S1100-0326S2022-11-04
B06211000327Aries-TS TSLIF Lumbar Interbody System1100-0327S1100-0327S2022-11-04
B06211000328Aries-TS TSLIF Lumbar Interbody System1100-0328S1100-0328S2022-11-04
B06211000329Aries-TS TSLIF Lumbar Interbody System1100-0329S1100-0329S2022-11-04
B06211000520Aries-TS TSLIF Lumbar Interbody System1100-0520S1100-0520S2022-11-04
B06211000521Aries-TS TSLIF Lumbar Interbody System1100-0521S1100-0521S2022-11-04
B06211000522Aries-TS TSLIF Lumbar Interbody System1100-0522S1100-0522S2022-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157075859ZAVATION INSERTERZavation LLCMAX2026-05-27
00810166522366X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
00810166522373X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
B70712535005S0Dual X Graft Tamp ShortAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010130DUALXS T/PLIF 15 DEG x 9-12MMAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010200DUALXS T/PLIF 18 DEG x 10-13MMAMPLIFY SURGICAL, INC.MAX2026-05-27
07613153046196AVS PLStryker CorporationOVD2015-09-14
07613153046196AVS PLStryker CorporationMAX2015-09-14
07613153046202AVS PLStryker CorporationMAX2015-09-14
07613153046219AVS PLStryker CorporationMAX2015-09-14
07613153046226AVS PLStryker CorporationOVD2015-09-14
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07613153046295AVS PLStryker CorporationOVD2015-09-14
07613153046301AVS PLStryker CorporationMAX2015-09-14
07613153046318AVS PLStryker CorporationOVD2015-09-14
07613153046325AVS PLStryker CorporationMAX2015-09-14
07613153046332AVS PLStryker CorporationMAX2015-09-14
07613153046349AVS PLStryker CorporationOVD2015-09-14
07613153046356AVS PLStryker CorporationMAX2015-09-14
07613153046356AVS PLStryker CorporationOVD2015-09-14
07613153046363AVS PLStryker CorporationMAX2015-09-14
07613153046363AVS PLStryker CorporationOVD2015-09-14
07613153046370AVS PLStryker CorporationOVD2015-09-14
07613153046394AVS TLStryker CorporationMAX2015-09-14
07613153046400AVS TLStryker CorporationOVD2015-09-14
07613153046400AVS TLStryker CorporationMAX2015-09-14
07613153046417AVS TLStryker CorporationMAX2015-09-14
07613153046417AVS TLStryker CorporationOVD2015-09-14
07613153046424AVS TLStryker CorporationMAX2015-09-14