FDA.reportPublic FDA data

Alliant Biotech

Primary DI
G611WD110060
Brand
Alliant Biotech
Company
MEDISURGE LLC
Model
26/-3.5
Catalog number
WD-1-1006
Device description
CoCr Femoral Head 26/-3.5mm
Published
2024-08-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961625000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961625000QUATROLOC FEMORAL COMPONENT & HEADWhiteside Biomechanics, Inc.1996-09-10LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G611WD110060PrimaryHIBCC0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8883071144mmorrissey@medisurge.com

Regulatory Flags#

DUNS number
119198202
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G611BIO110210Alliant BiotechBIO-1-1021BIO-1-10212024-08-16
G611BIO110220Alliant BiotechBIO-1-1022BIO-1-10222024-08-16
G611BIO110230Alliant BiotechBIO-1-1023BIO-1-10232024-08-16
G611BIO110240Alliant BiotechBIO-1-1024BIO-1-10242024-08-16
G611BIO11024B0Alliant BiotechBIO-1-1024-BBIO-1-1024-B2024-08-16
G611BIO11024C0Alliant BiotechBIO-1-1024-CBIO-1-1024-C2024-08-16
G611BIO110310Alliant BiotechBIO-1-1031BIO-1-10312024-08-16
G611BIO110320Alliant BiotechBIO-1-1032BIO-1-10322024-08-16
G611BIO110330Alliant BiotechBIO-1-1033BIO-1-10332024-08-16
G611BIO11033R0Alliant BiotechBIO-1-1033-RBIO-1-1033-R2024-08-16
G611BIO110340Alliant BiotechBIO-1-1034BIO-1-10342024-08-16
G611BIO11034R0Alliant BiotechBIO-1-1034-RBIO-1-1034-R2024-08-16
G611BIO110350Alliant BiotechBIO-1-1035BIO-1-10352024-08-16
G611BIO110360Alliant BiotechBIO-1-1036BIO-1-10362024-08-16
G611BIO110370Alliant BiotechBIO-1-1037BIO-1-10372024-08-16
G611BIO110810Alliant BiotechBIO-1-1081BIO-1-10812024-08-16
G611BIO110820Alliant BiotechBIO-1-1082BIO-1-10822024-08-16
G611BIO110830Alliant BiotechBIO-1-1083BIO-1-10832024-08-16
G611BIO110840Alliant BiotechBIO-1-1084BIO-1-10842024-08-16
G611WF110010Alliant Biotech15mm Cancellous Bone ScrewWF-1-10012024-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024713512G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713529G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713536G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713543G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713550G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713567G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713574G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713581G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713598G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713604G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713611G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713628G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713635G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713642G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713659G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713666G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713673G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713680G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713697G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713703G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713734G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713741G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713758G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713765G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713772G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713789G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713796G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713802G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713819G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713826G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03