FDA.reportPublic FDA data

Kyocera Medical Technologies, Inc.

Primary DI
00841523105755
Brand
Kyocera Medical Technologies, Inc.
Company
KYOCERA MEDICAL TECHNOLOGIES, INC.
Model
Cemented Hip
Catalog number
1601-322-080
Device description
Distal Centralizer 8mm
Published
2015-10-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141370000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141370000RENOVIS CEMENTED HIP SYSTEMRenovis Surgical Technologies, Inc.2014-09-02JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841523105755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841523105755008415231057558415231057550841523105755

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated femoral stem prosthesis, modularA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is composed of two or more separate segments designed to be joined, is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
116995646
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841523146871Kyocera Medical Technologies, Inc.S 1803180-004-0012025-04-08
00841523146888Kyocera Medical Technologies, Inc.S 1803180-004-0022025-04-08
00841523146901Kyocera Medical Technologies, Inc.S 1803180-005-0012025-04-08
00841523146918Kyocera Medical Technologies, Inc.S 1803180-005-0022025-04-08
00841523146932Kyocera Medical Technologies, Inc.S 1803180-006-0002025-04-08
00841523146949Kyocera Medical Technologies, Inc.S 1803180-006-0012025-04-08
00841523146956Kyocera Medical Technologies, Inc.S 1803180-007-0002025-04-08
00841523137060Kyocera Medical Technologies, Inc.S 1281063-730-6172019-01-17
00841523181360Kyocera Medical Technologies, Inc.Tesera-k PL2171-001-0012026-05-26
00841523181681Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1072026-05-26
00841523181698Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1082026-05-26
00841523181704Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1092026-05-26
00841523181711Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1102026-05-26
00841523181728Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1112026-05-26
00841523181735Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1122026-05-26
00841523181742Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1132026-05-26
00841523181759Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1142026-05-26
00841523181766Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1152026-05-26
00841523181773Kyocera Medical Technologies, Inc.Tesera-k PL2171-221-1162026-05-26
00841523181780Kyocera Medical Technologies, Inc.Tesera-k PL2171-229-1072026-05-26

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Primary DI, Brand, Company table
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07611996075038SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996095609SLR-PLUSSmith & Nephew, Inc.JDI2016-08-19
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00885556321942REDAPTSmith & Nephew, Inc.JDI2016-02-24
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00885556321843REDAPTSmith & Nephew, Inc.JDI2015-12-11
07611996013788SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996013795SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996013849SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996014990BOFOR/EP-FIT PLUS/PROMOS/MPFSmith & Nephew, Inc.JDI2015-11-25
07611996045208MODULAR-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996065343SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996076394SL-PLUSSmith & Nephew, Inc.JDI2015-11-25