FDA.report

Anatomic Trial Sizer with stop 14x14, H12mm

Primary DI
B806RO0318AA1214X140
Brand
Anatomic Trial Sizer with stop 14x14, H12mm
Company
Spineup, Inc.
Model
RO0318AA1214X14
Catalog number
RO0318AA1214X14
Device description
Anatomic Trial Sizer with stop 14x14, H12mm
Published
2024-09-16
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
HWTTemplate

Product Code Classifications

CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B806RO0318AA1214X140PrimaryHIBCC0

GMDN Terms

TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Device Sizes

TypeValueUnit
Depth14Millimeter
Height12Millimeter
Width14Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
786-910-0234contact@upgroup.tech

Regulatory Flags

DUNS number
116999578
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

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B806ISRO1214L10CB10ROMERO CERVICAL CAGE, W14xD12xH10ISRO1214L10CB1ISRO1214L10CB12023-08-24

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