FDA.reportPublic FDA data

43MM BRIDGEBACK RMR

Primary DI
00889024645868
Brand
43MM BRIDGEBACK RMR
Company
Zimmer, Inc.
Model
SSI006804
Catalog number
SSI006804
Published
2022-05-13
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
HWRDriver, Prosthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWRDriver, ProsthesisOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024645868PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024645868008890246458688890246458680889024645868

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
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
00888867500754Arthrex®ARTHREX, INC.HWR2026-03-13
00888867500761Arthrex®ARTHREX, INC.HWR2026-03-13
00888867500778Arthrex®ARTHREX, INC.HWR2026-03-13
00888867500839Arthrex®ARTHREX, INC.HWR2026-03-13
00888867500877Arthrex®ARTHREX, INC.HWR2026-03-13
10705034579085N/AMedos International SàrlHWR2026-03-05
G079C5080000250MIS Golden Isles Pedicle Screw System Intelivation, LLCHWR2026-01-30
0088902470557940mm Head PusherZimmer, Inc.HWR2026-01-16
04026575315727MP Reconstruction SystemWALDEMAR LINK GmbH & Co. KGHWR2026-01-06
00840180543535General InstrumentsALPHATEC SPINE, INC.HWR2025-12-31
04719886910766U2 Total Knee SystemUNITED ORTHOPEDIC CORP.HWR2025-11-13
04719886910902USTAR II Knee SystemUNITED ORTHOPEDIC CORP.HWR2025-11-13
10705034643564TRIALTISMedos International SàrlHWR2025-11-13
07640332476307SCARLET AL-T INSTRUMENTATIONSpineArt SAHWR2025-11-11
07640332476314SCARLET AL-T INSTRUMENTATIONSpineArt SAHWR2025-11-11
00190376662213IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662237IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662244IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662251IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662268IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662275IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662282IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662299IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662305IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00190376662312IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
00889797111331Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HWR2025-08-26
G079AOL1380Advantage -LUMBAR InterbodyIntelivation, LLCHWR2025-08-07
00763000879594ENDOSKELETON® TCSMEDTRONIC SOFAMOR DANEK, INC.HWR2025-07-25
10705034589725TRIALTIS Spine SystemDEPUY SPINE, LLCHWR2025-07-17
04719886909593U2 Total Knee SystemUNITED ORTHOPEDIC CORP.HWR2025-07-14