FDA.reportPublic FDA data

Equinoxe

Primary DI
10885862088970
Brand
Equinoxe
Company
Exactech, Inc.
Model
341-01-55
Catalog number
341-01-55
Device description
DRILL BIT, FRACTURE PLATE, 5.5mm, CANNULATED
Published
2022-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093978000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093978000EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEMExactech, Inc.2010-05-11HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862088970PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586208897010885862088970

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, reusableA shaft of metal intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) to clear a channel of the same dimension as the diameter of the shaft. This drill is cannulated, having a hollow centre, and is typically flexible so that it can be fed over a guiding pin that has been placed into the correct position prior to operation. This device is typically used in orthopaedic surgery for clearing of the intramedullary channel prior to the insertion of a prosthetic device. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter5.5Millimeter

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
00889095401820ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401844ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401868ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401882ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401905ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401929ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402285ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402438ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402483ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402537ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411263ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411287ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411300ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411324ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095611274ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
10886982350732VOLTSynthes GmbHHRS2026-09-25
10886982350749VOLTSynthes GmbHHRS2026-09-25
10886982350756VOLTSynthes GmbHHRS2026-09-25
10886982350763VOLTSynthes GmbHHRS2026-09-25
10886982350770VOLTSynthes GmbHHRS2026-09-25
10886982350787VOLTSynthes GmbHHRS2026-09-25
10886982350794VOLTSynthes GmbHHRS2026-09-25
10886982350800VOLTSynthes GmbHHRS2026-09-25
10886982350817VOLTSynthes GmbHHRS2026-09-25
10886982350824VOLTSynthes GmbHHRS2026-09-25
10886982350831VOLTSynthes GmbHHRS2026-09-25
10886982350848VOLTSynthes GmbHHRS2026-09-25
10886982350855VOLTSynthes GmbHHRS2026-09-25
10886982350862VOLTSynthes GmbHHRS2026-09-25
10886982350879VOLTSynthes GmbHHRS2026-09-25