FDA.reportPublic FDA data

ROMERO Self Tapping Screw, D3.5xL11mm

Primary DI
B806ISRO35T11SC20
Brand
ROMERO Self Tapping Screw, D3.5xL11mm
Company
Spineup, Inc.
Model
ISRO35T11SC2
Catalog number
ISRO35T11SC2
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B806ISRO35T11SC20PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Length11Millimeter
Outer Diameter3.5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B806ISRO1214L08CA10ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD12xH08ISRO1214L08CA1ISRO1214L08CA12023-10-03
B806ISRO1420L13CA10ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD14xH13ISRO1420L13CA1ISRO1420L13CA12023-10-04
B806ISRO1620A12CA10ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH12ISRO1620A12CA1ISRO1620A12CA12023-10-03
B806ISRO1214A04CB10ROMERO CERVICAL CAGE, W14xD12xH04ISRO1214A04CB1ISRO1214A04CB12023-08-28
B806ISRO1214A05CB10ROMERO CERVICAL CAGE, W14xD12xH05ISRO1214A05CB1ISRO1214A05CB12023-08-28
B806ISRO1214A06CB10ROMERO CERVICAL CAGE, W14xD12xH06ISRO1214A06CB1ISRO1214A06CB12023-08-28
B806ISRO1214A07CB10ROMERO CERVICAL CAGE, W14xD12xH07ISRO1214A07CB1ISRO1214A07CB12023-08-28
B806ISRO1214A08CB10ROMERO CERVICAL CAGE, W14xD12xH08ISRO1214A08CB1ISRO1214A08CB12023-08-28
B806ISRO1214A09CB10ROMERO CERVICAL CAGE, W14xD12xH09ISRO1214A09CB1ISRO1214A09CB12023-08-28
B806ISRO1214A10CB10ROMERO CERVICAL CAGE, W14xD12xH10ISRO1214A10CB1ISRO1214A10CB12023-08-28
B806ISRO1214A11CB10ROMERO CERVICAL CAGE, W14xD12xH11ISRO1214A11CB1ISRO1214A11CB12023-08-28
B806ISRO1214A12CB10ROMERO CERVICAL CAGE, W14xD12xH12ISRO1214A12CB1ISRO1214A12CB12023-08-28
B806ISRO1214A13CB10ROMERO CERVICAL CAGE, W14xD12xH13ISRO1214A13CB1ISRO1214A13CB12023-08-28
B806ISRO1214L04CB10ROMERO CERVICAL CAGE, W14xD12xH04ISRO1214L04CB1ISRO1214L04CB12023-08-24
B806ISRO1214L05CB10ROMERO CERVICAL CAGE, W14xD12xH05ISRO1214L05CB1ISRO1214L05CB12023-08-24
B806ISRO1214L06CB10ROMERO CERVICAL CAGE, W14xD12xH06ISRO1214L06CB1ISRO1214L06CB12023-08-24
B806ISRO1214L07CB10ROMERO CERVICAL CAGE, W14xD12xH07ISRO1214L07CB1ISRO1214L07CB12023-08-24
B806ISRO1214L08CB10ROMERO CERVICAL CAGE, W14xD12xH08ISRO1214L08CB1ISRO1214L08CB12023-08-24
B806ISRO1214L09CB10ROMERO CERVICAL CAGE, W14xD12xH09ISRO1214L09CB1ISRO1214L09CB12023-08-24
B806ISRO1214L10CB10ROMERO CERVICAL CAGE, W14xD12xH10ISRO1214L10CB1ISRO1214L10CB12023-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840283404245ClariVy™VY SPINE LLCODP2026-03-19
00840283404252ClariVy™VY SPINE LLCODP2026-03-19
00840283404269ClariVy™VY SPINE LLCODP2026-03-19
00840283404276ClariVy™VY SPINE LLCODP2026-03-19
00840283404283ClariVy™VY SPINE LLCODP2026-03-19
00840493416687LUX Expandable Interbody SystemXENIX MEDICAL LLCODP2026-03-13
00840493416694LUX Expandable Interbody SystemXENIX MEDICAL LLCODP2026-03-13
00840493416700LUX Expandable Interbody SystemXENIX MEDICAL LLCODP2026-03-13
00841193127521EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127538EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127545EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127552EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127569EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127576EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127583EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127590EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127606EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127613EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127620EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127637EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127644EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127651EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127668EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127675EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
10195860030421E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030438E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030445E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030452E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030506E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030537E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20