FDA.reportPublic FDA data

SA REAMER ADAPTER-ASSY

Primary DI
00889024632875
Brand
SA REAMER ADAPTER-ASSY
Company
Zimmer, Inc.
Model
SSI006711
Catalog number
SSI006711
Published
2022-05-06
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
00889024632875PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024632875008890246328758890246328750889024632875

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) 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
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
00889024712867PTH SHELL ADPTR LRGSSI008658SSI0086582026-08-25
00889024712874PTH BOOMSSI008680SSI0086802026-08-25
00889024712881PTH TROCARSSI008681SSI0086812026-08-25
008890247128986.5/8.0mm Countersink, Cannulated ZH QCSSI008697SSI0086972026-08-25
00889024712904RMR LONG KEYSSI008690SSI0086902026-08-25
00889024712911X BAR RMR ADPT TALLSSI008688SSI0086882026-08-25
00889024712928RMR SHORT KEYSSI008689SSI0086892026-08-25
00889024712935RMR SHORT KEY BENTSSI008691SSI0086912026-08-25
00889024712942RMR LONG KEY BENTSSI008692SSI0086922026-08-25
00889024713277Universal Uni Knee TensorSSI008695SSI0086952026-08-25
00889024713284Right Uni Knee TensorSSI008696SSI0086962026-08-25
00889024713291Left Uni Knee TensorSSI008694SSI0086942026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024712904RMR LONG KEYZimmer, Inc.HWR2026-08-25
00889024712911X BAR RMR ADPT TALLZimmer, Inc.HWR2026-08-25
00889024712928RMR SHORT KEYZimmer, Inc.HWR2026-08-25
00889024712935RMR SHORT KEY BENTZimmer, Inc.HWR2026-08-25
00889024712942RMR LONG KEY BENTZimmer, Inc.HWR2026-08-25
03701089545358AMPLITUDEAMPLITUDE SASHWR2026-07-29
03701089545365AMPLITUDEAMPLITUDE SASHWR2026-07-29
08809926260299InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260312InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260329InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260336InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260343InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260350InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260367InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260374InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260381InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260398InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260404InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
G079C5070000120Golden Isles Pedicle Screw SystemIntelivation, LLCHWR2026-04-22
07640332478462SCARLET® AC-TiSpineArt SAHWR2025-11-10
10603295559436INHANCE INTACTDEPUY (IRELAND)HWR2025-06-13
10603295551768INHANCE SHOULDER SYSTEMDEPUY (IRELAND)HWR2025-03-07
10603295551805INHANCE SHOULDER SYSTEMDEPUY (IRELAND)HWR2025-02-21
10603295560050INHANCE SHOULDER SYSTEMDEPUY (IRELAND)HWR2025-02-21
G079C5080000040MIS Golden Isles Pedicle Screw System Intelivation, LLCHWR2023-10-03
G079C5080000160MIS Golden Isles Pedicle Screw System Intelivation, LLCHWR2023-10-03
00887868561368VersaNail®Biomet Orthopedics, LLCHWR2023-09-07
09348215083069Dual Mobility Sleeve DriverSIGNATURE ORTHOPAEDICS PTY LTDHWR2023-01-27
G079C5070000030Golden Isles Pedicle Screw SystemIntelivation, LLCHWR2022-09-23
10603295547631INHANCEDEPUY (IRELAND)HWR2022-05-16