FDA.reportPublic FDA data

Z1 BROACH SZ 0, HYBRID

Primary DI
00889024706095
Brand
Z1 BROACH SZ 0, HYBRID
Company
Zimmer, Inc.
Model
SSI008469
Catalog number
SSI008469
Published
2026-02-23
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
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233476000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233476000Z1 Hip SystemOrchard Medical Development2024-02-08LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024706095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024706095008890247060958890247060950889024706095

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1 (800) 343-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
056038268
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024713505G7® TM Acetabular System1200013321200013322026-11-03
00889024713512G7® TM Acetabular System7574000427574000422026-11-03
00889024713529G7® TM Acetabular System7574000447574000442026-11-03
00889024713536G7® TM Acetabular System7574000467574000462026-11-03
00889024713543G7® TM Acetabular System7574000487574000482026-11-03
00889024713550G7® TM Acetabular System7574000507574000502026-11-03
00889024713567G7® TM Acetabular System7574000527574000522026-11-03
00889024713574G7® TM Acetabular System7574000547574000542026-11-03
00889024713581G7® TM Acetabular System7574000567574000562026-11-03
00889024713598G7® TM Acetabular System7574000587574000582026-11-03
00889024713604G7® TM Acetabular System7574000607574000602026-11-03
00889024713611G7® TM Acetabular System7574000627574000622026-11-03
00889024713628G7® TM Acetabular System7574000647574000642026-11-03
00889024713635G7® TM Acetabular System7574000667574000662026-11-03
00889024713642G7® TM Acetabular System7574000687574000682026-11-03
00889024713659G7® TM Acetabular System7574000707574000702026-11-03
00889024713666G7® TM Acetabular System7574000727574000722026-11-03
00889024713673G7® TM Acetabular System7574000747574000742026-11-03
00889024713680G7® TM Acetabular System7574000767574000762026-11-03
00889024713697G7® TM Acetabular System7574000787574000782026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024713512G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713512G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713529G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713529G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713536G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713536G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713543G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713543G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713550G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713550G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713567G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713567G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713574G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713574G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713581G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713581G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713598G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713598G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713604G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713604G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713611G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713611G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713628G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713628G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713635G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713635G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713642G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713642G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713659G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713659G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03