Natural-Hip™

Primary DI
00889024178489
Brand
Natural-Hip™
Company
Zimmer, Inc.
Model
9354-01-309
Published
2016-07-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K894051000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894051000PREMIER-TOTAL HIPIntermedics Orthopedics1989-08-28LWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024178489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024178489008890241784898890241784890889024178489

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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)348-2759zimmer.consumerrelations@zimmer.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

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Primary DI, Brand, Company table
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07611996074949SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996074956SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996074970SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996074987SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996074994SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996075007SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996075014SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996075038SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996095586SLR-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996095593SLR-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996095609SLR-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996095623SLR-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996095630SLR-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996095647SLR-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996095654SLR-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996095661SLR-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996095678SLR-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996103427POLARSTEMSmith & Nephew, Inc.LWJ2016-07-25
07611996103434POLARSTEMSmith & Nephew, Inc.LWJ2016-07-25
07611996103441POLARSTEMSmith & Nephew, Inc.LWJ2016-07-25
07611996103458POLARSTEMSmith & Nephew, Inc.LWJ2016-07-25