FDA.reportPublic FDA data

Alteon

Primary DI
10885862623843
Brand
Alteon
Company
Exactech, Inc.
Model
SPI-027055
Catalog number
SPI-027055
Device description
Slap Hammer Adaptor
Published
2023-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWBExtractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862623843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586262384310885862623843

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant-instrument extension adaptor, reusableA connecting device designed to join an orthopaedic implant to a surgical instrument, or a surgical instrument to another instrument, typically to create an extension for removal of the implant (e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve), or to connect two devices with incompatible interfaces. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
157565946
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
10885862656117Newton02-521-90-200402-521-90-20042026-05-27
10885862656124Newton02-521-90-200502-521-90-20052026-05-27
10885862656131Newton02-521-90-200602-521-90-20062026-05-27
10885862656148Newton02-521-90-200702-521-90-20072026-05-27
10885862656155Newton02-521-90-200802-521-90-20082026-05-27
10885862656162Newton02-521-90-200902-521-90-20092026-05-27
10885862656179Newton02-521-90-201002-521-90-20102026-05-27
10885862653697Alteon190-00-01190-00-012026-05-26
10885862653703Alteon190-00-02190-00-022026-05-26
10885862653710Alteon190-00-03190-00-032026-05-26
10885862653727Alteon190-00-04190-00-042026-05-26
10885862653734Alteon190-00-05190-00-052026-05-26
10885862653741Alteon190-00-06190-00-062026-05-26
10885862653758Alteon190-00-07190-00-072026-05-26
10885862653765Alteon190-00-08190-00-082026-05-26
10885862653772Alteon190-00-09190-00-092026-05-26
10885862653789Alteon190-00-10190-00-102026-05-26
10885862653796Alteon190-00-11190-00-112026-05-26
10885862653802Alteon190-00-12190-00-122026-05-26
10885862653819Alteon190-00-13190-00-132026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295543695ATTUNEDEPUY (IRELAND)HWB2025-10-31
10705034535364NADEPUY SPINE, LLCHWB2019-02-12
10705034535821NADEPUY SPINE, LLCHWB2019-02-12
10705034533650NADEPUY SPINE, LLCHWB2019-01-16
10705034533667NADEPUY SPINE, LLCHWB2019-01-16
10705034533674NADEPUY SPINE, LLCHWB2019-01-16
10705034533681NADEPUY SPINE, LLCHWB2019-01-16
10705034533698NADEPUY SPINE, LLCHWB2019-01-16
10705034533704NADEPUY SPINE, LLCHWB2019-01-16
10705034533711NADEPUY SPINE, LLCHWB2019-01-16
10705034533728NADEPUY SPINE, LLCHWB2019-01-16
10705034533735NADEPUY SPINE, LLCHWB2019-01-16
10705034533742NADEPUY SPINE, LLCHWB2019-01-16
10705034534060NADEPUY SPINE, LLCHWB2019-01-16
10705034534152NADEPUY SPINE, LLCHWB2019-01-16
10705034534169NADEPUY SPINE, LLCHWB2019-01-16
10705034497754N/ADEPUY SPINE, LLCHWB2018-11-05
10603295080763NADEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295087861NADEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295087878NADEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295090595GLOBAL APDEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295090649GLOBAL APDEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295156017RECLAIMDEPUY (IRELAND)HWB2018-09-24
10603295159087LPSDEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295171669S-ROMDEPUY (IRELAND)HWB2018-09-24
10603295171676S-ROMDEPUY (IRELAND)HWB2018-09-24
10603295171683S-ROMDEPUY (IRELAND)HWB2018-09-24
10603295178408NADEPUY (IRELAND)HWB2018-09-24
10603295181651S-ROM NOILESDEPUY (IRELAND)HWB2018-09-24
10603295248439SPECIALISTDEPUY (IRELAND)HWB2018-09-24