FDA.report

SPIRA-O

Primary DI
B030SPO1080120
Brand
SPIRA-O
Company
CAMBER SPINE TECHNOLOGIES, LLC
Model
SPO-108-012
Device description
25° Rake Curette
Published
2022-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HTFCurette

Product Code Classifications

CodeDeviceSpecialtyClass
HTFCuretteGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B030SPO1080120PrimaryHIBCC0

GMDN Terms

TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1 (484) 427-7060quality@cambermedtech.com

Regulatory Flags

DUNS number
054205979
Device count
1
DM exempt
false
Premarket exempt
true
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 DIBrandModelCatalogPublished
B030SCA151807090SPIRA-C IntegratedSCA-1518-07092025-08-04
B030SCA151807100SPIRA-C IntegratedSCA-1518-07102025-08-04
B030SCA151807110SPIRA-C IntegratedSCA-1518-07112025-08-04
B030SCA151807120SPIRA-C IntegratedSCA-1518-07122025-08-04
B030SCA5000010SPIRA-C IntegratedSCA-500-0012025-08-04
B030SCA5040010SPIRA-C IntegratedSCA-504-0012025-08-04
B030SCA5040020SPIRA-C IntegratedSCA-504-0022025-08-04
B030SCZ1034000SPIRA-C IntegratedSCZ-103-4002025-08-04
B030SCZ103400060SPIRA-C IntegratedSCZ-103-400-062025-08-04
B030SCZ103400070SPIRA-C IntegratedSCZ-103-400-072025-08-04
B030SCZ103400080SPIRA-C IntegratedSCZ-103-400-082025-08-04
B030SCZ103400090SPIRA-C IntegratedSCZ-103-400-092025-08-04
B030SCZ103400100SPIRA-C IntegratedSCZ-103-400-102025-08-04
B030SCZ103400110SPIRA-C IntegratedSCZ-103-400-112025-08-04
B030SCZ103400120SPIRA-C IntegratedSCZ-103-400-122025-08-04
B030SCZ1034020SPIRA-C IntegratedSCZ-103-4022025-08-04
B030SCZ1034030SPIRA-C IntegratedSCZ-103-4032025-08-04
B030SCZ1035000SPIRA-C IntegratedSCZ-103-5002025-08-04
B030SCZ1170150SPIRA-C IntegratedSCZ-117-0152025-08-04
B030SCZ1170160SPIRA-C IntegratedSCZ-117-0162025-08-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
24026704941692PILLINGTELEFLEX INCORPORATEDHTF2026-03-23
24026704941708PILLINGTELEFLEX INCORPORATEDHTF2026-03-23
00192896122871Spoon CuretteSONTEC INSTRUMENTS, INC.HTF2026-03-19
00810158219052PRINCETONPrinceton Medical Group, Inc.HTF2026-03-11
00190776393229MillenniumAvalign Technologies, Inc.HTF2026-03-04
00810168190297NAPACIFIC INSTRUMENTS, INC.HTF2026-03-03
00190776417260MillenniumAvalign Technologies, Inc.HTF2026-02-20
00190776416447MillenniumAvalign Technologies, Inc.HTF2026-02-16
00190776416669MillenniumAvalign Technologies, Inc.HTF2026-02-16
03662663109475Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109512Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109529Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109543Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109550Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109567Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
00190776416010MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776416027MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776416041MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776416058MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776416065MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776415785MillenniumAvalign Technologies, Inc.HTF2026-02-04
00190776415792MillenniumAvalign Technologies, Inc.HTF2026-02-04
00190776415808MillenniumAvalign Technologies, Inc.HTF2026-02-04
00190776415815MillenniumAvalign Technologies, Inc.HTF2026-02-04
00190776415822MillenniumAvalign Technologies, Inc.HTF2026-02-04
03662663083584ActivLHighridge Medical, LLCHTF2026-02-03
03662663083591ActivLHighridge Medical, LLCHTF2026-02-03
03662663083607ActivLHighridge Medical, LLCHTF2026-02-03
03662663083614ActivLHighridge Medical, LLCHTF2026-02-03
03662663083621ActivLHighridge Medical, LLCHTF2026-02-03