FDA.reportPublic FDA data

Pisces-SA

Primary DI
B06217205050
Brand
Pisces-SA
Company
Osseus Fusion Systems, LLC
Model
1720-5050
Catalog number
1720-5050
Device description
Bone Screw, Variable, Self-Tapping, 50mm, PISCES-SA
Published
2022-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

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
B06217205050PrimaryHIBCC0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
933442068
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B06234500010Pisces-SC Standalone Cervical Interbody3450-00103450-00102026-10-29
B06234500020Pisces-SC Standalone Cervical Interbody3450-00203450-00202026-10-29
B06234500030Pisces-SC Standalone Cervical Interbody3450-00303450-00302026-10-29
B06234500040Pisces-SC Standalone Cervical Interbody3450-00403450-00402026-10-29
B06234500050Pisces-SC Standalone Cervical Interbody3450-00503450-00502026-10-29
B06234500052Pisces-SC Standalone Cervical Interbody3450-00523450-00522026-10-29
B06234500053Pisces-SC Standalone Cervical Interbody3450-00533450-00532026-10-29
B06234500054Pisces-SC Standalone Cervical Interbody3450-00543450-00542026-10-29
B06234500061Pisces-SC Standalone Cervical Interbody3450-00613450-00612026-10-29
B06234500062Pisces-SC Standalone Cervical Interbody3450-00623450-00622026-10-29
B06234500063Pisces-SC Standalone Cervical Interbody3450-00633450-00632026-10-29
B06234500064Pisces-SC Standalone Cervical Interbody3450-00643450-00642026-10-29
B06234500070Pisces-SC Standalone Cervical Interbody3450-00703450-00702026-10-29
B06234500071Pisces-SC Standalone Cervical Interbody3450-00713450-00712026-10-29
B06234500080Pisces-SC Standalone Cervical Interbody3450-00803450-00802026-10-29
B06234500081Pisces-SC Standalone Cervical Interbody3450-00813450-00812026-10-29
B06234500090Pisces-SC Standalone Cervical Interbody3450-00903450-00902026-10-29
B06234500100Pisces-SC Standalone Cervical Interbody3450-01003450-01002026-10-29
B06234500110Pisces-SC Standalone Cervical Interbody3450-01103450-01102026-10-29
B06234500121Pisces-SC Standalone Cervical Interbody3450-01213450-01212026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G070SPX01505300000OneLIF™Novapproach Spine LLCOVD2026-10-30
00810017916191SABER-XA, Expandable Spacer, 37x28mm, 16mm, (18°)ELEVATION SPINE, INC.OVD2026-10-27
00810017916139SABER-XA, Anterior Plate, 34Wx11HELEVATION SPINE, INC.OVD2026-10-23
00810017916146SABER-XA, Anterior Plate, 34Wx13HELEVATION SPINE, INC.OVD2026-10-23
00810017916153SABER-XA, Anterior Plate, 34Wx16HELEVATION SPINE, INC.OVD2026-10-23
00810017916207SABER-XA, Anterior Plate, 37Wx11HELEVATION SPINE, INC.OVD2026-10-23
00810017916221SABER-XA, Anterior Plate, 37Wx16HELEVATION SPINE, INC.OVD2026-10-23
00810017916276SABER-XA, Anterior Plate, 40Wx11HELEVATION SPINE, INC.OVD2026-10-23
00810017916283SABER-XA, Anterior Plate, 40Wx13HELEVATION SPINE, INC.OVD2026-10-23
00810017916290SABER-XA, Anterior Plate, 40Wx16HELEVATION SPINE, INC.OVD2026-10-23
00840606187626Ventana ASPINAL ELEMENTS, INC.OVD2026-10-22
B06217500000Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-24
B06217500001Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-24
B06217900001Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-24
B06217200001Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-23
B06217205422Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-23
B06217205425Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-23
B06217205035Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205038Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205040Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205043Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205045Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205048Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205053Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205115Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205118Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205120Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205123Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205125Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205128Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19