FDA.report

SPIRA®-A Integrated

Primary DI
B030SAZ1070010
Brand
SPIRA®-A Integrated
Company
CAMBER SPINE TECHNOLOGIES, LLC
Model
SAZ-107-001
Device description
SPIRA®-A Integrated, Tamp
Published
2024-12-17
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

Product Codes

CodeName
HXGTamp

Product Code Classifications

CodeDeviceSpecialtyClass
HXGTampOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B030SAZ1070010PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical tamp, reusableA hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
false
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

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