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Neosys

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref G02 10001Ref G02 10041Ref G02 10191Ref G02 10131Ref G02 10051Ref G02 10021Ref G02 10101Ref G02 10121Ref G02 10071

by In2Bones SAS

Identity

Trade Name
NEOSYS EUDAMEDFDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
NEOSYS SINGLE USE INTRUMENTS SET EUDAMED
NEOSYS SINGLE USE SET FOOT 2.0-2.5 FDA UDI
NEOSYS SINGLE USE SET FOOT DMMO FDA UDI
NEOSYS SINGLE USE SET FOOT 2.0-2.5 DRILL "M" FDA UDI
NEOSYS SINGLE USE SET COMPLETE FDA UDI
NEOSYS SET SINGLE USE INSTRUMENTS FDA UDI
NEOSYS SINGLE USE SET FOOT 3.0-3.5 CANN DRILL "S" FDA UDI
NEOSYS SINGLE USE SET FOOT 2.0-2.5 CANN DRILL "S" FDA UDI
NEOSYS SINGLE USE SET FOOT 3.0-3.5 FDA UDI
NEOSYS SINGLE USE SET FOOT 2.0-2.5 DMMO FDA UDI
Model / Reference
G02 10001 EUDAMEDFDA UDI
G02 10041 EUDAMEDFDA UDI
G02 10191 EUDAMEDFDA UDI
G02 10131 EUDAMEDFDA UDI
G02 10051 EUDAMEDFDA UDI
G02 10021 EUDAMEDFDA UDI
G02 10101 EUDAMEDFDA UDI
G02 10121 EUDAMEDFDA UDI
G02 10071 EUDAMEDFDA UDI
Description
NEOSYS SINGLE USE SET FOOT 2.0-2.5 FDA UDI
NEOSYS SINGLE USE SET FOOT DMMO FDA UDI
NEOSYS SINGLE USE SET FOOT 2.0-2.5 DRILL "M" FDA UDI
NEOSYS SINGLE USE SET COMPLETE FDA UDI
NEOSYS SET SINGLE USE INSTRUMENTS FDA UDI
NEOSYS SINGLE USE SET FOOT 3.0-3.5 CANN DRILL "S" FDA UDI
NEOSYS SINGLE USE SET FOOT 2.0-2.5 CANN DRILL "S" FDA UDI
NEOSYS SINGLE USE SET FOOT 3.0-3.5 FDA UDI
NEOSYS SINGLE USE SET FOOT 2.0-2.5 DMMO FDA UDI

Identifiers

Catalog Number
G02 10021 FDA UDI
G02 10121 FDA UDI
G02 10101 FDA UDI
G02 10191 FDA UDI
G02 10001 FDA UDI
G02 10071 FDA UDI
G02 10051 FDA UDI
G02 10041 FDA UDI
G02 10131 FDA UDI
Primary DI / UDI-DI
03760225712191 EUDAMEDFDA UDI
03701337606114 EUDAMEDFDA UDI
03701337606275 EUDAMEDFDA UDI
03701337606206 EUDAMEDFDA UDI
03701337606121 EUDAMEDFDA UDI
03701337606091 EUDAMEDFDA UDI
03701337606176 EUDAMEDFDA UDI
03701337606190 EUDAMEDFDA UDI
03701337606145 EUDAMEDFDA UDI
Basic UDI-DI
B-03760225712191 EUDAMED
B-03701337606114 EUDAMED
B-03701337606275 EUDAMED
B-03701337606206 EUDAMED
B-03701337606121 EUDAMED
B-03701337606091 EUDAMED
B-03701337606176 EUDAMED
B-03701337606190 EUDAMED
B-03701337606145 EUDAMED
FDA Product Code
KDD FDA UDI
EMDN Code
P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Market of Registration
Belgium EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDIFDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Joint prosthesis implantation kit, single-use

Neosys by In2Bones SAS — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Joint prosthesis implantation kit, single-use.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
In2Bones SAS
EUDAMED SRN
FR-MF-000005246

Sources (27)

  • EUDAMED e41f713d-c722-40cf-9f47-34337eae43a7 61 fields · synced Aug 3, 2026
  • EUDAMED c25e103c-3b10-4cce-bb14-62e5a8a45d14 61 fields · synced May 16, 2026
  • EUDAMED 31d52a3b-77ea-4879-9825-209216d492b6 61 fields · synced May 17, 2026
  • EUDAMED e2214eed-c77b-4021-adf0-8a5e5d982745 61 fields · synced May 17, 2026
  • EUDAMED bd31c35f-4dfa-4272-b4f6-3fc20362a6b6 61 fields · synced May 18, 2026
  • EUDAMED 83ee3317-ea4d-467b-8b69-cf5c841a5446 61 fields · synced May 18, 2026
  • EUDAMED 43ca5065-0e45-43f1-b805-6714608d8b39 61 fields · synced May 18, 2026
  • EUDAMED deef86e9-8a9c-4557-88e3-80ba455de6eb 61 fields · synced May 18, 2026
  • EUDAMED 81e3b20f-3499-4c8c-b044-74201bd67ae1 61 fields · synced May 19, 2026
  • FDA UDI 5cbc13db-076a-4a14-b639-571a6f81e0f2 35 fields · synced May 26, 2026
  • FDA UDI dedc849b-8205-4bc9-b607-76001510629f 35 fields · synced May 29, 2026
  • FDA UDI 27b12135-5498-4e95-a6dd-c43342454f26 35 fields · synced May 30, 2026
  • FDA UDI 0022b491-7cfe-4939-86df-cd905d17a50b 35 fields · synced May 30, 2026
  • FDA UDI 7240149d-87f3-45e7-9d87-16ac776d695e 35 fields · synced May 30, 2026
  • FDA UDI 629bd2bd-70c9-4b4a-a828-7508b3c1d7cb 35 fields · synced May 30, 2026
  • FDA UDI d21296d8-30a7-4287-96e5-9f1b0c33887c 35 fields · synced May 30, 2026
  • FDA UDI 6560dec8-0b05-4c76-9683-02b6652a3752 35 fields · synced May 30, 2026
  • FDA UDI dc7aea0e-5567-43ba-97b3-e625d01dc13b 35 fields · synced May 30, 2026
  • EUDAMED c3156d0c-5a7a-473c-b8ba-63f77736791d 61 fields · synced Jul 9, 2026
  • EUDAMED ed7b40e0-436f-41ee-be33-e2bce53a354b 61 fields · synced Jul 11, 2026
  • EUDAMED 11ee2061-1b23-427b-91f2-1e7ae1cb75c5 61 fields · synced Jul 15, 2026
  • EUDAMED eaa87d34-aa4c-4585-aad1-2f62f98e5cb5 61 fields · synced Jul 17, 2026
  • EUDAMED 97592365-689b-4433-9025-7d73bf5ffb91 61 fields · synced Jul 26, 2026
  • EUDAMED 2c8ee820-123d-4640-b9ae-2265888dec94 61 fields · synced Jul 27, 2026
  • EUDAMED 9e6ec2a5-d6ce-430a-ad5e-fd5f3f4f3fb0 61 fields · synced Jul 30, 2026
  • EUDAMED 37a8050d-94b6-4a06-b0bc-e6fb23ee3aaf 61 fields · synced Aug 2, 2026
  • EUDAMED 47a2bc7a-3e63-44be-9521-3ab09faaa2d4 61 fields · synced Aug 3, 2026