Z1 BROACH SZ 5, HYBRID SSI008474

GUDID 00889024706149

Zimmer, Inc.

Bone file/rasp, manual, reusable
Primary Device ID00889024706149
NIH Device Record Keyccc802ad-5ecf-4936-a830-c7ba20fe0c02
Commercial Distribution StatusIn Commercial Distribution
Brand NameZ1 BROACH SZ 5, HYBRID
Version Model NumberSSI008474
Catalog NumberSSI008474
Company DUNS056038268
Company NameZimmer, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024706149 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024706149]

Moist Heat or Steam Sterilization


[00889024706149]

Moist Heat or Steam Sterilization


[00889024706149]

Moist Heat or Steam Sterilization


[00889024706149]

Moist Heat or Steam Sterilization


[00889024706149]

Moist Heat or Steam Sterilization


[00889024706149]

Moist Heat or Steam Sterilization


[00889024706149]

Moist Heat or Steam Sterilization


[00889024706149]

Moist Heat or Steam Sterilization


[00889024706149]

Moist Heat or Steam Sterilization


[00889024706149]

Moist Heat or Steam Sterilization


[00889024706149]

Moist Heat or Steam Sterilization


[00889024706149]

Moist Heat or Steam Sterilization


[00889024706149]

Moist Heat or Steam Sterilization


[00889024706149]

Moist Heat or Steam Sterilization


[00889024706149]

Moist Heat or Steam Sterilization


[00889024706149]

Moist Heat or Steam Sterilization


[00889024706149]

Moist Heat or Steam Sterilization


[00889024706149]

Moist Heat or Steam Sterilization


[00889024706149]

Moist Heat or Steam Sterilization


[00889024706149]

Moist Heat or Steam Sterilization


[00889024706149]

Moist Heat or Steam Sterilization


[00889024706149]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-03
Device Publish Date2026-02-23

Devices Manufactured by Zimmer, Inc.

00887868150876 - Affixus®2026-03-30
00887868150333 - Affixus®2026-03-27
00887868150340 - Affixus®2026-03-27
00887868150357 - Affixus®2026-03-27
00887868150364 - Affixus®2026-03-27
00887868150371 - Affixus®2026-03-27
00887868150388 - Affixus®2026-03-27
00887868150395 - Affixus®2026-03-27

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.