FDA.reportPublic FDA data

NA

Primary DI
10885862565129
Brand
NA
Company
Exactech, Inc.
Model
02-029-90-8123
Catalog number
02-029-90-8123
Device description
RE-CUT REFERENCER, 2 DEG VARUS/VALGUS
Published
2022-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862565129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586256512910885862565129

GMDN Terms#

Term, Definition table
TermDefinition
Osteotomy guide, reusableA surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle2degree
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
157565946
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885862653697Alteon190-00-01190-00-012026-05-26
10885862653703Alteon190-00-02190-00-022026-05-26
10885862653710Alteon190-00-03190-00-032026-05-26
10885862653727Alteon190-00-04190-00-042026-05-26
10885862653734Alteon190-00-05190-00-052026-05-26
10885862653741Alteon190-00-06190-00-062026-05-26
10885862653758Alteon190-00-07190-00-072026-05-26
10885862653765Alteon190-00-08190-00-082026-05-26
10885862653772Alteon190-00-09190-00-092026-05-26
10885862653789Alteon190-00-10190-00-102026-05-26
10885862653796Alteon190-00-11190-00-112026-05-26
10885862653802Alteon190-00-12190-00-122026-05-26
10885862653819Alteon190-00-13190-00-132026-05-26
10885862653826Alteon190-00-14190-00-142026-05-26
10885862653833Alteon190-00-15190-00-152026-05-26
10885862653840Alteon190-01-02190-01-022026-05-26
10885862653857Alteon190-01-03190-01-032026-05-26
10885862653864Alteon190-01-04190-01-042026-05-26
10885862653871Alteon190-01-05190-01-052026-05-26
10885862653888Alteon190-01-06190-01-062026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327670936TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327670950TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327670974TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327670981TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671032TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671049TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671056TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671094TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671100TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671131TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671148TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671186TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671209TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671216TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671230TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671247TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671254TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671261TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671278TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671285TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671315TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671322TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671346TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671377TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671384TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671407TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671421TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671445TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671469TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671483TriathlonHowmedica Osteonics Corp.MBH2026-02-26