FDA.report

b-ONE™ 12/14 Taper Femoral Head

Primary DI
00843575103604
Brand
b-ONE™ 12/14 Taper Femoral Head
Company
B-ONE ORTHO, CORP.
Model
8819053281
Catalog number
8819053281
Device description
HEAD TRIAL, 28MM DIAMETER, -3.5MM NECK LENGTH
Published
2019-03-15
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

Product Codes

CodeName
HWTTemplate

Product Code Classifications

CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00843575103604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00843575103604008435751036048435751036040843575103604

GMDN Terms

TermDefinition
Femoral head prosthesis trialA copy of a final femoral head prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size, and to help achieve the desired offset, leg-length, and range of motion of the final prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral stem trial or final prostheses; some may be used with explantation instruments during removal of implanted acetabulum cups. It is typically made of metal or polymer material and includes trial adapters used with large trial heads. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
081315444
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00843575127143MOBIO™ Total Knee System882133110988213311092026-03-06
00843575127150MOBIO™ Total Knee System882133111088213311102026-03-06
00843575127167MOBIO™ Total Knee System882133111188213311112026-03-06
00843575127174MOBIO™ Total Knee System882133111388213311132026-03-06
00843575127181MOBIO™ Total Knee System882133111688213311162026-03-06
00843575127198MOBIO™ Total Knee System882133111988213311192026-03-06
00843575127204MOBIO™ Total Knee System882133112288213311222026-03-06
00843575127211MOBIO™ Total Knee System882133112588213311252026-03-06
00843575127228MOBIO™ Total Knee System882133130988213313092026-03-06
00843575127235MOBIO™ Total Knee System882133131088213313102026-03-06
00843575127242MOBIO™ Total Knee System882133131188213313112026-03-06
00843575127259MOBIO™ Total Knee System882133131388213313132026-03-06
00843575127266MOBIO™ Total Knee System882133131688213313162026-03-06
00843575127273MOBIO™ Total Knee System882133131988213313192026-03-06
00843575127280MOBIO™ Total Knee System882133132288213313222026-03-06
00843575127297MOBIO™ Total Knee System882133132588213313252026-03-06
00843575127303MOBIO™ Total Knee System882133150988213315092026-03-06
00843575127310MOBIO™ Total Knee System882133151088213315102026-03-06
00843575127327MOBIO™ Total Knee System882133151188213315112026-03-06
00843575127334MOBIO™ Total Knee System882133151388213315132026-03-06

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00888118145321PURE PECTUSKLS-Martin L.P.HWT2026-03-23
00888118145338PURE PECTUSKLS-Martin L.P.HWT2026-03-23
00889024706347OSS RS ROT Hinged Knee Provisional 20MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706354OSS RS ROT Hinged Knee Provisional 22MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706361OSS RS ROT Hinged Knee Provisional 14MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706378OSS RS ROT Hinged Knee Provisional 12MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706385OSS RS ROT Hinged Knee Provisional 16MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706392OSS RS ROT Hinged Knee Provisional 18MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706514REDUCED Z1 STD NECK TRL SZ 10-12Zimmer, Inc.HWT2026-03-19
00889024706521REDUCED Z1 STD NECK TRL SZ 0-9Zimmer, Inc.HWT2026-03-19
04046826472061MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
04046826472078MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
04046826472085MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
10885862609588VantageExactech, Inc.HWT2026-03-19
10885862648037EquinoxeExactech, Inc.HWT2026-03-19
10885862648044EquinoxeExactech, Inc.HWT2026-03-19
10885862648051EquinoxeExactech, Inc.HWT2026-03-19
10885862648068EquinoxeExactech, Inc.HWT2026-03-19
10885862648075EquinoxeExactech, Inc.HWT2026-03-19
10885862648082EquinoxeExactech, Inc.HWT2026-03-19
10885862659712N/AExactech, Inc.HWT2026-03-19
10885862659729N/AExactech, Inc.HWT2026-03-19
10885862659736N/AExactech, Inc.HWT2026-03-19
10885862659750N/AExactech, Inc.HWT2026-03-19
10885862659767N/AExactech, Inc.HWT2026-03-19
10885862659774N/AExactech, Inc.HWT2026-03-19
10885862659781N/AExactech, Inc.HWT2026-03-19
10885862659804N/AExactech, Inc.HWT2026-03-19
10885862659811N/AExactech, Inc.HWT2026-03-19
10885862659835N/AExactech, Inc.HWT2026-03-19