FDA.reportPublic FDA data

NA

Primary DI
00889024049765
Brand
NA
Company
Zimmer, Inc.
Model
00-2328-092-03
Catalog number
00-2328-092-03
Published
2016-09-02
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
HRSPlate, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133246000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133246000ZIMMER DISTAL RADIUS PLATING SYSTEMZimmer, Inc.2013-12-17HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024049765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024049765008890240497658890240497650889024049765

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
056038268
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024701281Identity® Shoulder System11007733110077332026-06-10
00889024701298Identity® Shoulder System11007734110077342026-06-10
00889024701304Identity® Shoulder System11007735110077352026-06-10
00889024701311Identity® Shoulder System11007736110077362026-06-10
00889024701328Identity® Shoulder System11007737110077372026-06-10
00889024701335Identity® Shoulder System11007738110077382026-06-10
00889024701342Identity® Shoulder System11007739110077392026-06-10
00889024701359Identity® Shoulder System11007740110077402026-06-10
00889024701366Identity® Shoulder System11007741110077412026-06-10
00889024701373Identity® Shoulder System11007742110077422026-06-10
00889024701380Identity® Shoulder System11007743110077432026-06-10
00889024701397Identity® Shoulder System11007744110077442026-06-10
00889024701403Identity® Shoulder System11007745110077452026-06-10
00889024701410Identity® Shoulder System11007746110077462026-06-10
00889024701427Identity® Shoulder System11007747110077472026-06-10
00889024701434Identity® Shoulder System11007748110077482026-06-10
00889024701441Identity® Shoulder System11007749110077492026-06-10
00889024701458Identity® Shoulder System11007750110077502026-06-10
00889024701465Identity® Shoulder System11007751110077512026-06-10
00889024701472Identity® Shoulder System11007752110077522026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190446944331Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446944348Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952213Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952220Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952237Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952244Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952251Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952268Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952275Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952282Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952299Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952305Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952312Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952329Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446950110Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446950172Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446950189Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446950196Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446950202Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446950219Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446951964Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446951971Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446951988Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446951995Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446952015Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446952022Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446952039Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446952046Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446952060Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446952336Arsenal FootTrilliant Surgical, LLCHRS2026-06-24