FDA.reportPublic FDA data

PRX HUM CORTEX C-SINK PRE-CUTTER

Primary DI
00889024583870
Brand
PRX HUM CORTEX C-SINK PRE-CUTTER
Company
Zimmer, Inc.
Model
SSI005541
Catalog number
SSI005541
Published
2020-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181827000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181827000Affixus Natural Nail System Humeral NailZimmer GmbH2018-12-14HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024583870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024583870008890245838708890245838700889024583870

GMDN Terms#

Term, Definition table
TermDefinition
Surgical countersink, reusableA rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1 (800) 343-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
056038268
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024701281Identity® Shoulder System11007733110077332026-06-10
00889024701298Identity® Shoulder System11007734110077342026-06-10
00889024701304Identity® Shoulder System11007735110077352026-06-10
00889024701311Identity® Shoulder System11007736110077362026-06-10
00889024701328Identity® Shoulder System11007737110077372026-06-10
00889024701335Identity® Shoulder System11007738110077382026-06-10
00889024701342Identity® Shoulder System11007739110077392026-06-10
00889024701359Identity® Shoulder System11007740110077402026-06-10
00889024701366Identity® Shoulder System11007741110077412026-06-10
00889024701373Identity® Shoulder System11007742110077422026-06-10
00889024701380Identity® Shoulder System11007743110077432026-06-10
00889024701397Identity® Shoulder System11007744110077442026-06-10
00889024701403Identity® Shoulder System11007745110077452026-06-10
00889024701410Identity® Shoulder System11007746110077462026-06-10
00889024701427Identity® Shoulder System11007747110077472026-06-10
00889024701434Identity® Shoulder System11007748110077482026-06-10
00889024701441Identity® Shoulder System11007749110077492026-06-10
00889024701458Identity® Shoulder System11007750110077502026-06-10
00889024701465Identity® Shoulder System11007751110077512026-06-10
00889024701472Identity® Shoulder System11007752110077522026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982660086AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660109AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660123AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660147AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660161AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660185AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660208AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660222AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660246AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660260AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660284AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660307AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660321AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
B058AHN08165L1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
B058AHN08165R1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
10855068008423Lock ActivatorCURVAFIX, INC.HSB2022-06-20
10855068008492Inserter/ExtractorCURVAFIX, INC.HSB2022-06-20
10855068008539Sterilization Case, OuterCURVAFIX, INC.HSB2022-06-20
10855068008621Ring Lock, Long InserterCURVAFIX, INC.HSB2022-06-20
03701037310649FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310656FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310663FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310670FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310687FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310694FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310700FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310717FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310724FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310731FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310748FLEX NAILFX SOLUTIONSHSB2021-10-26