FDA.reportPublic FDA data

Pisces-SA

Primary DI
B06217607043
Brand
Pisces-SA
Company
Osseus Fusion Systems, LLC
Model
1760-7043
Catalog number
1760-7043
Device description
3mm Kerrison Rongeur, Angled, Bayonetted, 350mm
Published
2022-05-20
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
false

Product Codes#

Code, Name table
CodeName
HTXRongeur

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

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
B06217607043PrimaryHIBCC0

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
00190776437497MillenniumAvalign Technologies, Inc.HTX2026-11-04
B382SD9180201110Surgical DirectSurgical Direct, Inc.HTX2026-11-04
00190776437367MillenniumAvalign Technologies, Inc.HTX2026-11-02
00190776437466MillenniumAvalign Technologies, Inc.HTX2026-11-02
B382SD914763020Surgical DirectSurgical Direct, Inc.HTX2026-10-30
B382SD914763010Surgical DirectSurgical Direct, Inc.HTX2026-10-28
00724995267919Snowden-PencerSTERIS Deutschland GmbHHTX2026-10-27
00724995312992V. MuellerSTERIS Deutschland GmbHHTX2026-10-27
10840642182149Spine Wave InstrumentsSpine Wave, Inc.HTX2026-10-21
10840642182156Spine Wave InstrumentsSpine Wave, Inc.HTX2026-10-21
10840642182163Spine Wave InstrumentsSpine Wave, Inc.HTX2026-10-21
B382SD9228132200Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132300Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132310Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132340Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132350Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132360Surgical DirectSurgical Direct, Inc.HTX2026-10-20
00190776435394MillenniumAvalign Technologies, Inc.HTX2026-10-19
B382SD488603LH0Surgical DirectSurgical Direct, Inc.HTX2026-09-23
B382SD482012L0Surgical DirectSurgical Direct, Inc.HTX2025-10-06
B382SD9212021100Surgical DirectSurgical Direct, Inc.HTX2022-12-01
B382SD921226190Surgical DirectSurgical Direct, Inc.HTX2022-12-01
B06217607041Pisces-SAOsseus Fusion Systems, LLCHTX2022-05-23
B06217607047Pisces-SAOsseus Fusion Systems, LLCHTX2022-05-23
B06217607054Pisces-SAOsseus Fusion Systems, LLCHTX2022-05-23
B06217607040Pisces-SAOsseus Fusion Systems, LLCHTX2022-05-20
B06217607042Pisces-SAOsseus Fusion Systems, LLCHTX2022-05-20
B06217607044Pisces-SAOsseus Fusion Systems, LLCHTX2022-05-20
B06217607045Pisces-SAOsseus Fusion Systems, LLCHTX2022-05-20
B06217607046Pisces-SAOsseus Fusion Systems, LLCHTX2022-05-20