FDA.reportPublic FDA data

Phoenix

Primary DI
00889024564176
Brand
Phoenix
Company
Zimmer, Inc.
Model
SSI004129
Catalog number
SSI004129
Published
2019-02-18
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024564176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024564176008890245641768890245641760889024564176

GMDN Terms#

Term, Definition table
TermDefinition
Bone nail driverA hand-held manual surgical instrument designed to impart force on another instrument or directly on a bone fixation nail to insert the nail into tissue (i.e., to drive the nail into the intramedullary canal). It is typically made of high-grade stainless steel or titanium (Ti). 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
00889024707467Z1® Hip System6117776126117776122026-07-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150083473Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-08-03
B382SD480033220Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD480090Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD4834330Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
00190776407391MillenniumAvalign Technologies, Inc.LXH2026-07-31
00840606191579Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191630Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191647Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191678Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191685Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191692Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191708Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191722Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191739Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191777Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191920Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191937Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191968Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191999Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00888867532236Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532243Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532250Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532267Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532274Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544819Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544826Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544833Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544840Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544857Arthrex®ARTHREX, INC.LXH2026-07-31