FDA.reportPublic FDA data

Innomed, Inc.

Primary DI
00840277105769
Brand
Innomed, Inc.
Company
INNOMED, INC.
Model
3630-05
Catalog number
3630-05
Device description
Tibial Component Extractor Body without Blades or Block
Published
2020-03-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HWMOsteotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840277105769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840277105769008402771057698402771057690840277105769

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). 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
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
00840277133588Innomed, Inc.2056-132056-132026-04-17
00840277133595Innomed, Inc.2056-142056-142026-04-17
00840277133601Innomed, Inc.2056-152056-152026-04-17
00840277132499Innomed, Inc.3009-L-D3009-L-D2025-07-03
00840277132185Innomed, Inc.3001-D3001-D2025-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811099624INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
09348811110442INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
09348811111289INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
10381780503316Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10381780503323Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10381780503330Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10381780503347Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10381780503354Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10603295080770NADEPUY (IRELAND)HWM2018-09-24
10603295080787NADEPUY (IRELAND)HWM2018-09-24
10603295080794NADEPUY (IRELAND)HWM2018-09-24
10603295083160SIGMADEPUY (IRELAND)HWM2018-09-24
10603295083191SIGMADEPUY (IRELAND)HWM2018-09-24
10603295090403GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295090410GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295090427GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295090434GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295090441GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295090458GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295122739NADEPUY (IRELAND)HWM2018-09-24
10603295122746NADEPUY (IRELAND)HWM2018-09-24
10603295122753NADEPUY (IRELAND)HWM2018-09-24
10603295122760NADEPUY (IRELAND)HWM2018-09-24
10603295122777NADEPUY (IRELAND)HWM2018-09-24
10603295122784NADEPUY (IRELAND)HWM2018-09-24
10603295122791NADEPUY (IRELAND)HWM2018-09-24
10603295123071MORELANDDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295123088MORELANDDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295123095MORELANDDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295123101MORELANDDEPUY ORTHOPAEDICS, INC.HWM2018-09-24