FDA.reportPublic FDA data

Natural-Hip™

Primary DI
00889024178991
Brand
Natural-Hip™
Company
Zimmer, Inc.
Model
9354-15-010
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
00889024178991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024178991008890241789918890241789910889024178991

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
00889024711464Comp Mini Humeral Tray Trial Stem AdapterSSI008664SSI0086642026-08-25
008890247114712.9 JuggerKnot Self-Punching ObturatorSSI008672SSI0086722026-08-25
008890247114882.9 JuggerKnot Self-Punching CannulaSSI008671SSI0086712026-08-25
00889024712294Pin Target AssemblySSI001470SSI0014702026-08-25
00889024712300Z1 POSTERIOR HAMMR ADPTRSSI008666SSI0086662026-08-25
00889024712317Z1 ANTERIOR HAMMR ADPTRSSI008665SSI0086652026-08-25
00889024712843PTH SHELL PSTNR ASSYSSI008611SSI0086112026-08-25
00889024712850PTH SHELL ADPTR SMLLSSI008612SSI0086122026-08-25
00889024712867PTH SHELL ADPTR LRGSSI008658SSI0086582026-08-25
00889024712874PTH BOOMSSI008680SSI0086802026-08-25
00889024712881PTH TROCARSSI008681SSI0086812026-08-25
008890247128986.5/8.0mm Countersink, Cannulated ZH QCSSI008697SSI0086972026-08-25
00889024712904RMR LONG KEYSSI008690SSI0086902026-08-25
00889024712911X BAR RMR ADPT TALLSSI008688SSI0086882026-08-25
00889024712928RMR SHORT KEYSSI008689SSI0086892026-08-25
00889024712935RMR SHORT KEY BENTSSI008691SSI0086912026-08-25
00889024712942RMR LONG KEY BENTSSI008692SSI0086922026-08-25
00889024713277Universal Uni Knee TensorSSI008695SSI0086952026-08-25
00889024713284Right Uni Knee TensorSSI008696SSI0086962026-08-25
00889024713291Left Uni Knee TensorSSI008694SSI0086942026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982895006TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895075TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895082TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895099TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895105TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895112TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895136TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895143TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895150TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895167TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895174TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895181TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895198TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895204TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895211TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895228TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895235TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895242TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895266TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895273TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895280TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895297TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895303TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895310TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14