FDA.reportPublic FDA data

Pisces-SA

Primary DI
B06217500010
Brand
Pisces-SA
Company
Osseus Fusion Systems, LLC
Model
1750-0010
Catalog number
1750-0010
Device description
Awl, Straight
Published
2022-05-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWJAwl

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

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
B06217500010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone awlA spike-like, orthopaedic, surgical instrument that is used to bore holes in bone. It is typically designed as a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end. It is manually-operated by the surgeon who rotates the point back and forth on the bone whilst exerting pressure onto the handle. This operation will penetrate the hard outer bone and create a passage into, e.g., a medullary canal. It is typically made of high-grade stainless steel, titanium (Ti) and a synthetic material for the handle (e.g., Tufnol). This is a reusable device intended to be sterilized prior to use.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311245376Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HWJ2026-04-30
04048844406547n/aimplantcast GmbHHWJ2026-04-07
04052536216161uCentumUlrich GmbH & Co. KGHWJ2026-03-31
00860015151308EnFix Instrument Kit - CompleteTETROUS, INC.HWJ2026-02-24
00887868287473Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLCHWJ2025-11-12
03662663108126Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCHWJ2025-11-12
03662663109949InViZia Anterior Cervical Plate SystemHighridge Medical, LLCHWJ2025-11-12
03662663128759PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCHWJ2025-11-12
03662663129015Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHWJ2025-11-12
07640375234773SCARLET AL-T INSTRUMENTATIONSpineArt SAHWJ2025-11-10
08059386744338Orthopaedic Surgical InstrumentsCITIEFFE SRLHWJ2025-11-06
00763000674410n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-26
09120129291507Awl, Curved, CannulatedI.T.S. GmbHHWJ2025-10-21
09120129291514Awl TrocarI.T.S. GmbHHWJ2025-10-21
00763000878245n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-20
00840180541050General InstrumentsALPHATEC SPINE, INC.HWJ2025-10-17
00763000885243n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-11
00816342025522AWLPARCUS MEDICAL LLCHWJ2025-09-16
04047844128190CYLOX STSIGNUS Medizintechnik GmbHHWJ2025-05-27
04047844128206CYLOX STSIGNUS Medizintechnik GmbHHWJ2025-05-27
00841732134393GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732134409GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732134416GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732134423GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732135406GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732139411GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732139428GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732163850GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-09-14
00841732163935GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-09-14
008100747560374WEB Medical4web MedicalHWJ2023-02-13