FDA.reportPublic FDA data

Custom Femoral Lateralizing Reamer

Primary DI
00889024710580
Brand
Custom Femoral Lateralizing Reamer
Company
Zimmer, Inc.
Model
SSI008673
Catalog number
SSI008673
Published
2026-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTOReamer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024710580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024710580008890247105808890247105800889024710580

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024699939N/A1200020041200020042026-10-20
00889024699946N/A1200020051200020052026-10-20
00889024699953Alliance Glenoid, Identity Humeral1200060141200060142026-10-20
00889024709164CANNULATED 1.5MM HEX DRIVERSSI004137SSI0041372026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERSSI004138SSI0041382026-10-19
00889024715196T6 Driver 127mm AO QCSSI008712SSI0087122026-10-19
00889024715202T8 Driver 127mm AO QCSSI008713SSI0087132026-10-19
00889024715295Persona Extended V/V Guide Assembly (MFS)SSI008760SSI0087602026-10-19
00889024715271Affixus®2113060432113060432026-10-06
00889024707160G7® Vivacit-E®30104005301040052026-09-30
00889024707184G7® Vivacit-E®30103603301036032026-09-30
00889024707207G7® Vivacit-E®30104407301044072026-09-30
00889024711464Comp Mini Humeral Tray Trial Stem AdapterSSI008664SSI0086642026-08-25
008890247114712.9 JuggerKnot Self-Punching ObturatorSSI008672SSI0086722026-08-25
008890247114882.9 JuggerKnot Self-Punching CannulaSSI008671SSI0086712026-08-25
00889024712294Pin Target AssemblySSI001470SSI0014702026-08-25
00889024712300Z1 POSTERIOR HAMMR ADPTRSSI008666SSI0086662026-08-25
00889024712317Z1 ANTERIOR HAMMR ADPTRSSI008665SSI0086652026-08-25
00889024712843PTH SHELL PSTNR ASSYSSI008611SSI0086112026-08-25
00889024712850PTH SHELL ADPTR SMLLSSI008612SSI0086122026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810128463918VersiTomic RR Retrograde Reamer 4.5 x 10.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
00810112598537DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598544DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598551DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598568DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598575DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598599DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598605DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598612DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598629DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598636DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112592269TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592276TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592283TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592290TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592306TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592313TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592320TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592337TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592344TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592351TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592368TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592375TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592382TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592399TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00850310006434CrossTIE™ Reamer 2.2mmCROSSROADS EXTREMITY SYSTEMSHTO2023-01-05
00850310006441CrossTIE™ Reamer 2.5mmCROSSROADS EXTREMITY SYSTEMSHTO2023-01-05
00850310006458CrossTIE™ Reamer 2.7mmCROSSROADS EXTREMITY SYSTEMSHTO2023-01-05
00850310006465CrossTIE™ Reamer 3.0mmCROSSROADS EXTREMITY SYSTEMSHTO2023-01-05
00815432028641MotoBAND CP Reamer, 2.0mmCROSSROADS EXTREMITY SYSTEMSHTO2022-11-30