FDA.reportPublic FDA data

EXULT Tibial Insert

Primary DI
08800017265445
Brand
EXULT Tibial Insert
Company
Corentec Co., Ltd
Model
K3.IBX.5786-24T
Device description
EXULT Tibial Insert PS XLPE #11 24mm
Published
2026-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192507000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192507000LOSPA II Knee SystemCorentec Co., Ltd.2019-12-11JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800017265445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800017265445088000172654458800017265445

Contacts#

Phone, Email table
PhoneEmail
+82269374902ra@corentec.com

Regulatory Flags#

DUNS number
688739895
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800017265438EXULT Tibial InsertK3.IBX.5786-22T2026-11-05
08800017276182LOSPAKA.STA.00132026-10-29
08806373878039LOSPAKB.STC.00102026-10-29
08806373889653LOSPA01.61.1702026-10-29
08806373894190LOSPA01.61.1212026-10-29
08809945895311EXULT Special Instrument(CM)KZ.026.Z0032026-10-15
08809945895328EXULT Special Instrument(CM)KZ.026.Z0122026-10-15
08809945895335EXULT Special Instrument(CM)KZ.026.Z0112026-10-15
08809945895342EXULT Special Instrument(CM)KZ.026.Z0102026-10-15
08809945895359EXULT Special Instrument(CM)KZ.026.Z0092026-10-15
08809945895366EXULT Special Instrument(CM)KZ.026.Z0082026-10-15
08809945895373EXULT Special Instrument(CM)KZ.026.Z0072026-10-15
08809945895380EXULT Special Instrument(CM)KZ.026.Z0062026-10-15
08809945895397EXULT Special Instrument(CM)KZ.026.Z0052026-10-15
08809945895403EXULT Special Instrument(CM)KZ.026.Z0042026-10-15
08800068958112BENCOX THR SystemHA.0C3.02842021-07-20
08800068946966BENCOXHA.018.28352026-07-01
08800068946973BENCOXHA.018.40622026-07-01
08800068963666BENCOXHA.018.36422026-07-01
08806373897344BENCOXHA.018.28372026-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800017265438EXULT Tibial InsertCorentec Co., LtdJWH2026-11-05
00192629475007EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475014EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475021EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475038EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475045EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475052EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475069EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475076EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475083EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475090EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475106EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475113EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475120EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475137EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475144EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475151EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475168EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475175EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475182EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475199EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475205EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475212EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475229EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475236EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475243EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475250EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475267EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475274EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475281EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03