FDA.reportPublic FDA data

Pisces-SA

Primary DI
B06217607038
Brand
Pisces-SA
Company
Osseus Fusion Systems, LLC
Model
1760-7038
Catalog number
1760-7038
Device description
Osteotome
Published
2022-05-24
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
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
B06217607038PrimaryHIBCC0

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
00190776438005MillenniumAvalign Technologies, Inc.HWM2026-11-05
00190776438012MillenniumAvalign Technologies, Inc.HWM2026-11-05
00190776437589MillenniumAvalign Technologies, Inc.HWM2026-11-04
08809974816141Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWM2026-11-03
G383S1093WM3265403X2SURJEXSURJEXHWM2026-10-31
G383S1093WM3265406X8SURJEXSURJEXHWM2026-10-31
G383S1093WM3265412X3SURJEXSURJEXHWM2026-10-31
00840329838836BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.HWM2026-10-30
00192896123946Micro OsteotomeSONTEC INSTRUMENTS, INC.HWM2026-10-27
00190776435516MillenniumAvalign Technologies, Inc.HWM2026-10-20
00190776435523MillenniumAvalign Technologies, Inc.HWM2026-10-20
00190776435592MillenniumAvalign Technologies, Inc.HWM2026-10-20
00190776437671MilleniumAvalign Technologies, Inc.HWM2026-10-20
00190776437732MilleniumAvalign Technologies, Inc.HWM2026-10-20
00190776437817MilleniumAvalign Technologies, Inc.HWM2026-10-20
00190776435127MillenniumAvalign Technologies, Inc.HWM2026-10-15
00190776435134MillenniumAvalign Technologies, Inc.HWM2026-10-15
00840277133915Innomed, Inc.INNOMED, INC.HWM2026-10-09
00190776434007MillenniumAvalign Technologies, Inc.HWM2026-10-08
00190776436261MillenniumAvalign Technologies, Inc.HWM2026-10-08
G141548807040Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-10-07
G141548807060Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-10-07
G141549966080Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-10-07
G141646640020Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-10-07
B7687715080Buxton Biomedical, IncBUXTON BIOMEDICAL, INC.HWM2026-10-06
00190776432935MillenniumAvalign Technologies, Inc.HWM2026-09-30
00840329838676BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.HWM2026-09-30
00840329838683BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.HWM2026-09-30
G14164746930Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-09-30
G141647481020Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-09-30