FDA.reportPublic FDA data

PSN TM TIB DRILL GDE

Primary DI
00889024682399
Brand
PSN TM TIB DRILL GDE
Company
Zimmer, Inc.
Model
SSI007712
Catalog number
SSI007712
Published
2025-01-13
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
HXYBrace, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXYBrace, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024682399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024682399008890246823998890246823990889024682399

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning 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 [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) 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) 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
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
10885862605764EPICExactech, Inc.HXY2026-04-28
05055662970593ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-08-14
05055662971293Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
05055662971309Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
05055662971316Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
05055662971323Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
00810027271594Citrelock ACL Tibial Drill Guide, Flat HookAcuitive Technologies, Inc.HXY2024-12-03
00191083044569Meniscus Allograft Transplantation (MAT)Rti Surgical, Inc.HXY2024-10-14
04049197096812RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXY2024-07-16
04049197096744RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXY2024-07-15
04026575534678LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGHXY2024-07-11
04026575534739LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGHXY2024-07-11
04049197187848RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXY2024-06-28
00840183516031BR Surgical, LLCBR Surgical, LLCHXY2024-06-03
00840183516048BR Surgical, LLCBR Surgical, LLCHXY2024-06-03
M73910290060TransFasten-LSF, Offset GuideCAPTIVA SPINE, INC.HXY2024-04-25
M73910290130TransFasten - LSF, Sharp Guide Pin Ø3.2mm x 229mmCAPTIVA SPINE, INC.HXY2024-04-25
M73910290140TransFasten - LSF, Blunt Guide Pin Ø3.2mm x 229mmCAPTIVA SPINE, INC.HXY2024-04-25
M73910290150TransFasten - LSF, Blunt Guide Pin Ø3.2mm x 457mmCAPTIVA SPINE, INC.HXY2024-04-25
M73910290170TransFasten - LSF, Open-Ended Offset GuideCAPTIVA SPINE, INC.HXY2024-04-25
M73910290180TransFasten - LSF, Parallel GuideCAPTIVA SPINE, INC.HXY2024-04-25
05055662969825COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969832COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969849COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969856COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969863COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969870COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
M7392030002104-Hole Drill GuideCAPTIVA SPINE, INC.HXY2024-03-11
08033860019105BIOPSYBELLBIOPSYBELL SRLHXY2024-02-23
08033860019112BIOPSYBELLBIOPSYBELL SRLHXY2024-02-23