FDA.report

ROMERO Self Drilling Screw, D3.5xL10mm

Primary DI
B806ISRO35D10SC20
Brand
ROMERO Self Drilling Screw, D3.5xL10mm
Company
Spineup, Inc.
Model
ISRO35D10SC2
Catalog number
ISRO35D10SC2
Device description
The Romero Cervical Cage is an anterior Cervical interbody device consisting of a PEEK interbody cage with radiographic markers and Titanium (Ti-6Al-4V ELI) fixation screws for cages with screw holes.
Published
2023-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications

CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B806ISRO35D10SC20PrimaryHIBCC0

GMDN Terms

TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes

TypeValueUnit
Length10Millimeter
Outer Diameter3.5Millimeter

Sterilization Methods

Method

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B806ISRO1214L08CA10ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD12xH08ISRO1214L08CA1ISRO1214L08CA12023-10-03
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B806ISRO1214L07CB10ROMERO CERVICAL CAGE, W14xD12xH07ISRO1214L07CB1ISRO1214L07CB12023-08-24
B806ISRO1214L08CB10ROMERO CERVICAL CAGE, W14xD12xH08ISRO1214L08CB1ISRO1214L08CB12023-08-24
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