FDA.reportPublic FDA data

U1™ Hip

Primary DI
04719872173021
Brand
U1™ Hip
Company
UNITED ORTHOPEDIC CORP.
Model
9203-1201
Catalog number
9203-1201
Device description
Cup reamer handle
Published
2017-06-26
Public version status
Update
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
04719872173021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872173021047198721730214719872173021

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic reamer handleA hand-held surgical device that is attached to the proximal end of an orthopaedic reamer shaft to allow the operator to manually rotate the cutting device. It typically has a T-shaped design and is made of a high-grade stainless steel alloy; it is available in a variety of sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+886229294567service@uoc.com.tw

Regulatory Flags#

DUNS number
656700556
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719886896466United Hip System1209-12421209-12422026-09-24
04719886896473United Hip System1209-12441209-12442026-09-24
04719886896480United Hip System1209-12481209-12482026-09-24
04719886896497United Hip System1209-12521209-12522026-09-24
04719886896503United Hip System1209-12541209-12542026-09-24
04719886896510United Hip System1209-12581209-12582026-09-24
04719886896527United Hip System1209-12621209-12622026-09-24
04719886896534United Hip System1209-12661209-12662026-09-24
04719886896541United Hip System1209-18481209-18482026-09-24
04719886896558United Hip System1209-18521209-18522026-09-24
04719886896565United Hip System1209-18541209-18542026-09-24
04719886896572United Hip System1209-18581209-18582026-09-24
04719886896589United Hip System1209-18621209-18622026-09-24
04719886896596United Hip System1209-18661209-18662026-09-24
04719886896633United Hip System1309-10461309-10462026-09-24
04719886896640United Hip System1309-10481309-10482026-09-24
04719886896657United Hip System1309-10501309-10502026-09-24
04719886896664United Hip System1309-10521309-10522026-09-24
04719886896671United Hip System1309-10541309-10542026-09-24
04719886896688United Hip System1309-10561309-10562026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
00840606186223ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
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