FDA.reportPublic FDA data

NA

Primary DI
10885862594044
Brand
NA
Company
Exactech, Inc.
Model
SPI-037148
Catalog number
SPI-037148
Device description
LBS 3 ANGLE GUIDE
Published
2022-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K033883000
K093360000
K111400000
K123687000
K140302000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033883000OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABIExactech, Inc.2004-02-13JWH
K093360000OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5TExactech, Inc.2010-01-11JWH
K111400000OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENTExactech, Inc.2011-07-28JWH
K123687000OPTETRAK LOGIC POROUS FEMORAL COMPONENTExactech, Inc.2013-03-20JWH
K140302000OPTETRAK LOGIC POROUS FEMORAL COMPONENTSExactech, Inc.2014-07-30MBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862594044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586259404410885862594044

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
157565946
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885862032102Novation160-20-11160-20-112015-08-10
10885862064035Optetrak244-24-09244-24-092015-10-30
10885862307132Truliant02-022-49-251102-022-49-25112017-05-16
10885862313058Optetrak Logic02-012-44-260902-012-44-26092017-02-16
10885862313065Optetrak Logic02-012-44-261102-012-44-26112017-02-16
10885862313072Optetrak Logic02-012-44-261302-012-44-26132017-02-16
10885862313089Optetrak Logic02-012-44-261502-012-44-26152017-02-16
10885862313218Optetrak Logic02-012-35-210902-012-35-21092017-02-16
10885862313225Optetrak Logic02-012-35-211102-012-35-21112017-02-16
10885862313232Optetrak Logic02-012-35-211302-012-35-21132017-02-16
10885862316271Optetrak Logic02-012-35-211702-012-35-21172017-02-16
10885862316288Optetrak Logic02-012-35-211902-012-35-21192017-02-16
10885862316356Optetrak Logic02-012-44-261702-012-44-26172017-02-16
10885862316363Optetrak Logic02-012-44-261902-012-44-26192017-02-16
10885862135049NAT2-5052T2-50522022-09-19
10885862135056NAT2-5458T2-54582022-09-19
10885862135063NAT2-6064T2-60642022-09-19
10885862135070NAT2-6670T2-66702022-09-19
10885862135636NAT8-4448T8-44482022-09-19
10885862135643NAT8-5052T8-50522022-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192629005419ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005426ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005433ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005440ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005457ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005464ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005488ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005495ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005501ADVANCEMicroport Orthopedics Inc.JWH2026-09-18
00192629005518ADVANCEMicroport Orthopedics Inc.JWH2026-09-18
00192629005549ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005556ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005563ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005570ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629082854EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082861EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082878EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082885EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082892EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082908EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082915EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082922EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082939EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082946EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082953EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082960EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082977EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082984EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082991EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629083004EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18