FDA.reportPublic FDA data

Romero Lordotic Rasp with Stop 20x16, H07mm

Primary DI
B806RO0213LI0720X160
Brand
Romero Lordotic Rasp with Stop 20x16, H07mm
Company
Spineup, Inc.
Model
RO0213LI0720X16
Catalog number
RO0213LI0720X16
Device description
Romero Lordotic Rasp with Stop 20x16, H07mm
Published
2024-05-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B806RO0213LI0720X160PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth16Millimeter
Height7Millimeter
Width20Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
786-910-0234contact@upgroup.tech

Regulatory Flags#

DUNS number
116999578
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B806RO2100V1080Ball Joint Tap with Stop D3.5xL08RO2100V108RO2100V1082024-09-17
B806RO2101V1090Ball Joint Tap with Stop D3.5xL09RO2101V109RO2101V1092024-09-17
B806RO2102V1100Ball Joint Tap with Stop D3.5xL10RO2102V110RO2102V1102024-09-17
B806RO2103V1110Ball Joint Tap with Stop D3.5xL11RO2103V111RO2103V1112024-09-17
B806RO2104V1120Ball Joint Tap with Stop D3.5xL12RO2104V112RO2104V1122024-09-17
B806RO2105V1130Ball Joint Tap with Stop D3.5xL13RO2105V113RO2105V1132024-09-17
B806RO2106V1140Ball Joint Tap with Stop D3.5xL14RO2106V114RO2106V1142024-09-17
B806RO2107V1150Ball Joint Tap with Stop D3.5xL15RO2107V115RO2107V1152024-09-17
B806RO2108V1160Ball Joint Tap with Stop D3.5xL16RO2108V116RO2108V1162024-09-17
B806RO2109V1170Ball Joint Tap with Stop D3.5xL17RO2109V117RO2109V1172024-09-17
B806RO2110V1180Ball Joint Tap with Stop D3.5xL18RO2110V118RO2110V1182024-09-17
B806RO2111V1190Ball Joint Tap with Stop D3.5xL19RO2111V119RO2111V1192024-09-17
B806RO2112V1200Ball Joint Tap with Stop D3.5xL20RO2112V120RO2112V1202024-09-17
B806RO0002LFIX0Romero Lateral Finishing Impactor XLRO0002LFIXRO0002LFIX2024-10-14
B806RO0027FIZZ0Romero Finishing ImpactorRO0027FIZZRO0027FIZZ2024-10-14
B806RO0028LFIZ0Romero Lateral Finishing ImpactorRO0028LFIZRO0028LFIZ2024-10-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
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00840606186230ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03