FDA.reportPublic FDA data

TM Handle

Primary DI
00889024588967
Brand
TM Handle
Company
Zimmer, Inc.
Model
SSI005889
Catalog number
SSI005889
Published
2020-06-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172767000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172767000Zimmer Trabecular Metal Reverse Shoulder System, Mini GlenoidZimmer, Inc.2017-11-30PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024588967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024588967008890245889678890245889670889024588967

GMDN Terms#

Term, Definition table
TermDefinition
Bone-coring punch, reusableA hand-held manual surgical instrument designed to cut out (core) sections of bone during surgery. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when pressed into the bone and gently rotated will penetrate and cut through the bone allowing that section to be removed. It is and is available in various cutting head sizes, and is not primarily intended for soft-tissue coring. 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
00811596031961CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-07-17
00811596031978CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-07-17
00811596031985CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-07-17
00811596031992EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-17
05404028001288SurgiCase PlannerMaterialise NVKWS2026-07-16
00811596031695EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031701EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031718EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031725EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031732EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031749EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031657EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031664EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031671EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031688EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00889024707047Signature ONE Software PackageOrthosoft IncKWT2026-07-10
00889024707047Signature ONE Software PackageOrthosoft IncKWS2026-07-10
03701037315897ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315903ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315910ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315927ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315934ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315941ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315958ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315965ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315972ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315989ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315996ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037316009ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037316535ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26