FDA.reportPublic FDA data

NA

Primary DI
00889024038110
Brand
NA
Company
Zimmer, Inc.
Model
1292-97
Catalog number
00-1292-097-00
Published
2016-07-27
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
HXSTWISTER, WIRE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXSTwister, WireOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024038110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024038110008890240381108890240381100889024038110

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
056038268
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024081024XtraFix® Large External Fixation System00-5207-024-3000-5207-024-302016-08-09
00889024081055XtraFix® Large External Fixation System00-5207-032-3000-5207-032-302016-07-27
00889024081062XtraFix® Large External Fixation System00-5207-040-1000-5207-040-102016-07-28
00889024081079XtraFix® Large External Fixation System00-5207-040-7000-5207-040-702016-07-28
00889024081086XtraFix® Large External Fixation System00-5207-045-1000-5207-045-102016-07-28
00889024081093XtraFix® Large External Fixation System00-5210-009-0100-5210-009-012016-09-28
00889024081109XtraFix® Large External Fixation System00-5210-009-0200-5210-009-022016-09-28
00889024081147XtraFix® Large External Fixation System00-5210-019-0100-5210-019-012016-09-28
00889024081154XtraFix® Large External Fixation System00-5210-029-0100-5210-029-012016-09-28
00889024081178XtraFix® Large External Fixation System00-5210-040-0000-5210-040-002016-09-28
00889024081185XtraFix® Large External Fixation System00-5210-040-0100-5210-040-012016-09-28
00889024081192XtraFix® Large External Fixation System00-5210-040-0200-5210-040-022016-09-28
00889024081208XtraFix® Large External Fixation System00-5210-040-0300-5210-040-032016-09-28
00889024081215XtraFix® Large External Fixation System00-5210-040-0400-5210-040-042016-09-28
00889024081239XtraFix® Large External Fixation System00-5210-040-0600-5210-040-062016-09-28
00889024081253XtraFix® Large External Fixation System00-5210-050-0100-5210-050-012016-09-28
00889024081260XtraFix® Large External Fixation System00-5210-050-0200-5210-050-022016-09-28
00889024081277XtraFix® Large External Fixation System00-5210-050-0300-5210-050-032016-09-28
00889024081284XtraFix® Large External Fixation System00-5210-050-0400-5210-050-042016-09-28
00889024081307XtraFix® Large External Fixation System00-5210-050-0600-5210-050-062016-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B8034803200ORTHOMEDORTHO-MED, INC.HXS2026-04-16
B8034803220ORTHOMEDORTHO-MED, INC.HXS2026-04-16
B8034803240ORTHOMEDORTHO-MED, INC.HXS2026-04-16
00888867500730Arthrex®ARTHREX, INC.HXS2026-03-13
00888867500747Arthrex®ARTHREX, INC.HXS2026-03-13
09348811105875INKAThe Trustee for KAISER FAMILY TRUSTHXS2025-11-26
04052536081097uCentumUlrich GmbH & Co. KGHXS2025-07-29
04052536081103uCentumUlrich GmbH & Co. KGHXS2025-07-29
04052536010585uCentumUlrich GmbH & Co. KGHXS2025-07-24
00190776394073MillenniumAvalign Technologies, Inc.HXS2025-05-06
00192896121379Wire TwisterSONTEC INSTRUMENTS, INC.HXS2025-04-11
00190776387372MillenniumAvalign Technologies, Inc.HXS2024-09-09
04049197086950RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXS2024-06-25
00192896116887Axel Wire Twister/CutterSONTEC INSTRUMENTS, INC.HXS2024-03-08
00888515056404BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
00888515204638BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
00888515204645BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
00888515204652BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
00888515204669BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
00888515204683BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
10840199532510Rod Holder ClampKOROS U.S.A., INC.HXS2024-01-31
00840199532513Rod Holder ClampKOROS U.S.A., INC.HXS2024-01-31
G586N2567460Novo SurgicalNOVO SURGICAL, INC.HXS2023-12-18
G586N8716610Novo SurgicalNOVO SURGICAL, INC.HXS2023-12-18
G586N98716620Novo SurgicalNOVO SURGICAL, INC.HXS2023-12-18
00192896115828Wire TwisterSONTEC INSTRUMENTS, INC.HXS2023-11-16
00190776301842MillenniumAvalign Technologies, Inc.HXS2023-11-15
00190776053406AvalignAvalign Technologies, Inc.HXS2023-09-28
00190776331559MILLENNIUMAvalign Technologies, Inc.HXS2023-09-28
00190776331566MILLENNIUMAvalign Technologies, Inc.HXS2023-09-28