FDA.reportPublic FDA data

Extremities

Primary DI
00889024577527
Brand
Extremities
Company
Zimmer, Inc.
Model
SSI005288
Catalog number
SSI005288
Published
2019-07-01
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
HXEFork

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXEForkOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024577527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024577527008890245775278890245775270889024577527

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). 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
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024710580Custom Femoral Lateralizing ReamerSSI008673SSI0086732026-07-20
00889024711495Z1 ExtractorSSI008663SSI0086632026-07-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889797111317Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HXE2025-08-26
00191083033204Cross-Fuse® II PEEK IBF SystemPioneer Surgical Technology, Inc.HXE2024-12-18
00191083033211Cross-Fuse® II PEEK IBF SystemPioneer Surgical Technology, Inc.HXE2024-12-12
00191083033198Cross-Fuse® II PEEK IBF SystemPioneer Surgical Technology, Inc.HXE2024-03-31
00842962170779HNM MedicalHNM STAINLESS, LLC.HXE2024-03-07
00190776337773MillenniumAvalign Technologies, Inc.HXE2023-06-23
00191083033181Cross-Fuse® II PEEK IBF SystemPioneer Surgical Technology, Inc.HXE2023-03-31
04047844111765COSYSIGNUS Medizintechnik GmbHHXE2023-03-15
00191083033174Cross-Fuse® II PEEK IBF SystemPioneer Surgical Technology, Inc.HXE2022-03-31
B922F00400270ACURA Stabilization System - Rod Lever/ Reduction ForkINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITEDHXE2022-03-21
00840192715241FAICO CMF SystemFAICO MEDICAL LLCHXE2021-04-20
00840192715548FAICO CMF SystemFAICO MEDICAL LLCHXE2021-04-20
08800037544964ANAX™ 5.5 CT SPINAL SYSTEMCG MedTech Co.,Ltd.HXE2020-11-14
04038653164134AESCULAPAesculap AGHXE2020-07-06
04046963780128ACTIV CAesculap AGHXE2020-04-24
04046963783143ACTIV CAesculap AGHXE2020-04-24
04038653403943NOVOCARTAesculap AGHXE2020-04-23
08800037523969ANAX™ 5.5 CT SPINAL SYSTEMCG MedTech Co.,Ltd.HXE2020-01-12
08800015999939ANAX™ 5.5 CT SPINAL SYSTEMCG MedTech Co.,Ltd.HXE2019-07-29
00840019925853PSS SystemPRECISION SPINE, INC.HXE2019-03-27
07640139349149OTELO INSTRUMENTATIONSpineArt SAHXE2019-02-01
00888118120144FORKKLS-Martin L.P.HXE2018-11-22
00846468011208Cross-Fuse® II PEEK VBR/IBF SystemPioneer Surgical Technology, Inc.HXE2018-10-06
00888118064400FORKKLS-Martin L.P.HXE2018-09-26
24026704291865KMEDICTELEFLEX INCORPORATEDHXE2018-09-15
08800015951982Optima™ Spinal SystemCG MedTech Co.,Ltd.HXE2017-11-02
08800015959438OPTIMA™ ZS Spinal SystemCG MedTech Co.,Ltd.HXE2017-10-31
08800015959414OPTIMA™ ZS Spinal SystemCG MedTech Co.,Ltd.HXE2017-10-31
M697C06700430Certex Spinal Fixation SystemXtant Medical Holdings, Inc.HXE2017-04-01
10889981080419MalibuSeaspine Orthopedics CorporationHXE2016-05-02