Pisces-SA

Primary DI
B06217607102
Brand
Pisces-SA
Company
Osseus Fusion Systems, LLC
Model
1760-7102
Catalog number
1760-7102
Device description
Paddle Shaver, 9mm
Published
2022-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWMOsteotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

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
B06217607102PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotome blade, reusableA sharp component of an orthopaedic osteotome intended to be attached to a dedicated handle (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is typically flat or curved (concave) in design and bevelled on one or both sides; it is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
933442068
Device count
1
Lot or batch
true
Sterilization required before use
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

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10381780503316Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
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10381780503354Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
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10603295083160SIGMADEPUY (IRELAND)HWM2018-09-24
10603295083191SIGMADEPUY (IRELAND)HWM2018-09-24
10603295090403GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295090410GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295090427GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
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10603295090458GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
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10603295122791NADEPUY (IRELAND)HWM2018-09-24
10603295123071MORELANDDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
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