FDA.reportPublic FDA data

Innomed, Inc.

Primary DI
00840277132741
Brand
Innomed, Inc.
Company
INNOMED, INC.
Model
4175-01NB
Catalog number
4175-01NB
Device description
Whelan Stem Extractor 13.5mm No Bolts
Published
2025-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00840277132741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840277132741008402771327418402771327410840277132741

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic inorganic implant inserter/extractor, reusableA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
878427491
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840277133625Innomed, Inc.666066602026-05-29
00840277133632Innomed, Inc.6660-L6660-L2026-05-29
00840277133649Innomed, Inc.6660-R6660-R2026-05-29
00840277133656Innomed, Inc.259625962026-05-29
00840277133663Innomed, Inc.5256-015256-012026-05-29
00840277132505Innomed, Inc.3009-R-D3009-R-D2026-04-24
00840277133618Innomed, Inc.4090-EXT24090-EXT22026-04-21
00840277133458Innomed, Inc.392239222026-04-17
00840277133465Innomed, Inc.2056-012056-012026-04-17
00840277133472Innomed, Inc.2056-022056-022026-04-17
00840277133489Innomed, Inc.2056-032056-032026-04-17
00840277133496Innomed, Inc.2056-042056-042026-04-17
00840277133502Innomed, Inc.2056-062056-062026-04-17
00840277133519Innomed, Inc.2056-072056-072026-04-17
00840277133526Innomed, Inc.2056-082056-082026-04-17
00840277133533Innomed, Inc.2056-052056-052026-04-17
00840277133540Innomed, Inc.2056-092056-092026-04-17
00840277133557Innomed, Inc.2056-102056-102026-04-17
00840277133564Innomed, Inc.2056-112056-112026-04-17
00840277133571Innomed, Inc.2056-122056-122026-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295543695ATTUNEDEPUY (IRELAND)HWB2025-10-31
00818069011031TecometTECOMET INC.HWB2023-08-10
00818069011048TecometTECOMET INC.HWB2023-08-10
00818069011055TecometTECOMET INC.HWB2023-08-10
00818069011062TecometTECOMET INC.HWB2023-08-10
00818069011079TecometTECOMET INC.HWB2023-08-10
00818069011086TecometTECOMET INC.HWB2023-08-10
00818069011093TecometTECOMET INC.HWB2023-08-10
00818069011109TecometTECOMET INC.HWB2023-08-10
00818069011116TecometTECOMET INC.HWB2023-08-10
00841435120365TecometTECOMET INC.HWB2022-10-03
00841435111226TecometTECOMET INC.HWB2020-10-09
00818069014858TecometTECOMET INC.HWB2020-10-09
00841435100688TecometTECOMET INC.HWB2020-10-09
00841435100695TecometTECOMET INC.HWB2020-10-09
00818069014339TecometTECOMET INC.HWB2020-08-20
00818069014346TecometTECOMET INC.HWB2020-08-20
00818069014353TecometTECOMET INC.HWB2020-08-20
00818069014360TecometTECOMET INC.HWB2020-08-07
00818069014377TecometTECOMET INC.HWB2020-08-07
00818069014384TecometTECOMET INC.HWB2020-08-07
00818069014391TecometTECOMET INC.HWB2020-08-07
00818069014407TecometTECOMET INC.HWB2020-08-07
00818069014414TecometTECOMET INC.HWB2020-08-07
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