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Neofit®
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref V27 ST010Ref V30 ST016Ref V27 ST114Ref V27 ST116Ref V30 ST018Ref V27 ST012Ref V27 ST118Ref V30 ST118Ref V30 ST112Ref V27 ST112Ref V30 ST012Ref V30 ST116Ref V27 ST020Ref V27 ST120Ref V27 ST110Ref V27 ST016
by In2Bones SAS
Identity
- Trade Name
- NEOFIT® EUDAMEDFDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- NEOFIT SCREW EUDAMEDNEOFIT SCREW - NON-LOCKING DIAM 3.0MM - LG 12MM FDA UDINEOFIT SCREW - NON-LOCKING DIAM 2.7MM - LG 12MM FDA UDINEOFIT SCREW - NON-LOCKING DIAM 2.7MM - LG 10MM FDA UDINEOFIT SCREW - LOCKING DIAM 3.0MM - LG 16MM FDA UDINEOFIT SCREW - LOCKING DIAM 2.7MM - LG 10MM FDA UDINEOFIT SCREW - LOCKING DIAM 2.7MM - LG 20MM FDA UDINEOFIT SCREW - NON-LOCKING DIAM 3.0MM - LG 16MM FDA UDINEOFIT SCREW - LOCKING DIAM 2.7MM - LG 14MM FDA UDINEOFIT SCREW - LOCKING DIAM 2.7MM - LG 16MM FDA UDINEOFIT SCREW - LOCKING DIAM 2.7MM - LG 18MM FDA UDINEOFIT SCREW - NON-LOCKING DIAM 2.7MM - LG 20MM FDA UDINEOFIT SCREW - LOCKING DIAM 3.0MM - LG 12MM FDA UDINEOFIT SCREW - LOCKING DIAM 2.7MM - LG 12MM FDA UDINEOFIT SCREW - LOCKING DIAM 3.0MM - LG 18MM FDA UDINEOFIT SCREW - NON-LOCKING DIAM 2.7MM - LG 16MM FDA UDINEOFIT SCREW - NON-LOCKING DIAM 3.0MM - LG 18MM FDA UDI
- Model / Reference
- V27 ST010 EUDAMEDFDA UDIV30 ST016 EUDAMEDFDA UDIV27 ST114 EUDAMEDFDA UDIV27 ST116 EUDAMEDFDA UDIV30 ST018 EUDAMEDFDA UDIV27 ST012 EUDAMEDFDA UDIV27 ST118 EUDAMEDFDA UDIV30 ST118 EUDAMEDFDA UDIV30 ST112 EUDAMEDFDA UDIV27 ST112 EUDAMEDFDA UDIV30 ST012 EUDAMEDFDA UDIV30 ST116 EUDAMEDFDA UDIV27 ST020 EUDAMEDFDA UDIV27 ST120 EUDAMEDFDA UDIV27 ST110 EUDAMEDFDA UDIV27 ST016 EUDAMEDFDA UDI
- Description
- NEOFIT SCREW - NON-LOCKING DIAM 3.0MM - LG 12MM FDA UDINEOFIT SCREW - NON-LOCKING DIAM 2.7MM - LG 12MM FDA UDINEOFIT SCREW - NON-LOCKING DIAM 2.7MM - LG 10MM FDA UDINEOFIT SCREW - LOCKING DIAM 3.0MM - LG 16MM FDA UDINEOFIT SCREW - LOCKING DIAM 2.7MM - LG 10MM FDA UDINEOFIT SCREW - LOCKING DIAM 2.7MM - LG 20MM FDA UDINEOFIT SCREW - NON-LOCKING DIAM 3.0MM - LG 16MM FDA UDINEOFIT SCREW - LOCKING DIAM 2.7MM - LG 14MM FDA UDINEOFIT SCREW - LOCKING DIAM 2.7MM - LG 16MM FDA UDINEOFIT SCREW - LOCKING DIAM 2.7MM - LG 18MM FDA UDINEOFIT SCREW - NON-LOCKING DIAM 2.7MM - LG 20MM FDA UDINEOFIT SCREW - LOCKING DIAM 3.0MM - LG 12MM FDA UDINEOFIT SCREW - LOCKING DIAM 2.7MM - LG 12MM FDA UDINEOFIT SCREW - LOCKING DIAM 3.0MM - LG 18MM FDA UDINEOFIT SCREW - NON-LOCKING DIAM 2.7MM - LG 16MM FDA UDINEOFIT SCREW - NON-LOCKING DIAM 3.0MM - LG 18MM FDA UDI
Identifiers
- Catalog Number
- V30 ST012 FDA UDIV27 ST012 FDA UDIV27 ST010 FDA UDIV30 ST116 FDA UDIV27 ST110 FDA UDIV27 ST120 FDA UDIV30 ST016 FDA UDIV27 ST114 FDA UDIV27 ST116 FDA UDIV27 ST118 FDA UDIV27 ST020 FDA UDIV30 ST112 FDA UDIV27 ST112 FDA UDIV30 ST118 FDA UDIV27 ST016 FDA UDIV30 ST018 FDA UDI
- Primary DI / UDI-DI
- 03760225712672 EUDAMEDFDA UDI03760225712825 EUDAMEDFDA UDI03760225712757 EUDAMEDFDA UDI03760225712764 EUDAMEDFDA UDI03760225712832 EUDAMEDFDA UDI03760225712689 EUDAMEDFDA UDI03760225712771 EUDAMEDFDA UDI03760225712894 EUDAMEDFDA UDI03760225712863 EUDAMEDFDA UDI03760225712740 EUDAMEDFDA UDI03760225712801 EUDAMEDFDA UDI03760225712887 EUDAMEDFDA UDI03760225712726 EUDAMEDFDA UDI03760225712788 EUDAMEDFDA UDI03760225712733 EUDAMEDFDA UDI03760225712702 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760225712672 EUDAMEDB-03760225712825 EUDAMEDB-03760225712757 EUDAMEDB-03760225712764 EUDAMEDB-03760225712832 EUDAMEDB-03760225712689 EUDAMEDB-03760225712771 EUDAMEDB-03760225712894 EUDAMEDB-03760225712863 EUDAMEDB-03760225712740 EUDAMEDB-03760225712801 EUDAMEDB-03760225712887 EUDAMEDB-03760225712726 EUDAMEDB-03760225712788 EUDAMEDB-03760225712733 EUDAMEDB-03760225712702 EUDAMED
- 510(k) Number
- K160995 FDA UDI
- FDA Product Code
- HRS FDA UDI
- EMDN Code
- P09120503 OSTEOSYNTHESIS SCREW-PLATE SYSTEMS EUDAMED
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Neofit® by In2Bones SAS — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03760225712672 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- In2Bones SAS
- EUDAMED SRN
- FR-MF-000005246
Sources (48)
- EUDAMED ee258e44-d270-4a37-8f03-95f40d075ae3 61 fields · synced Jul 29, 2026
- EUDAMED 7053c254-15b0-4f09-b322-122f2efe1dbb 61 fields · synced May 16, 2026
- EUDAMED c79eded9-4613-4a52-9886-84f8a80382e7 61 fields · synced May 17, 2026
- EUDAMED 4f86c473-087f-423c-bcf6-93fd5a66b0f5 61 fields · synced May 17, 2026
- EUDAMED e686d0ee-4bd1-4589-b0ca-f59951b70888 61 fields · synced May 17, 2026
- EUDAMED a476abe0-fd2f-4955-a7a5-0eba183c59d5 61 fields · synced May 17, 2026
- EUDAMED 34b98f44-2746-4bc6-af39-b7b04cf22aa8 61 fields · synced May 17, 2026
- EUDAMED d64381eb-c5d0-4d06-9766-dce87915e21c 61 fields · synced May 17, 2026
- EUDAMED ad536499-1b08-4833-9760-a1c4c1f012b4 61 fields · synced May 17, 2026
- EUDAMED 97bdd6f6-2767-4580-80f0-af48c00ad3fa 61 fields · synced May 17, 2026
- EUDAMED 47b9544b-4638-4dd2-b9d6-2eeb023c57f4 61 fields · synced May 17, 2026
- EUDAMED 1f6914ff-7cef-4835-a553-ec2bd211d141 61 fields · synced May 18, 2026
- EUDAMED ffe494a0-a2b9-4ed1-bd20-babcb469f0dd 61 fields · synced May 18, 2026
- EUDAMED fe8eea02-7fc6-4fac-b0af-80069baf55a3 61 fields · synced May 18, 2026
- EUDAMED c585bf6e-1d96-4cab-969b-2955a4ab98cd 61 fields · synced May 18, 2026
- EUDAMED 70e05c83-b92c-4b33-80c8-f1e895ba181d 61 fields · synced May 18, 2026
- FDA UDI d0f24878-66be-4a94-aa5c-f3dae0029456 37 fields · synced May 29, 2026
- FDA UDI eb69daa3-5915-4252-9c0f-6f549bd65ced 37 fields · synced May 29, 2026
- FDA UDI 2b1c1366-f2ea-4e5e-b7ee-18becc01a409 37 fields · synced May 29, 2026
- FDA UDI 20256e94-74ff-453a-8f65-d48dd3d2908a 37 fields · synced May 30, 2026
- FDA UDI 429c692e-f53c-48cb-a2ea-525c2e919b41 37 fields · synced May 30, 2026
- FDA UDI ae06c7c3-13e0-4dea-86b6-a341d24b1057 37 fields · synced May 30, 2026
- FDA UDI 7027db8e-bfad-4ab4-8d51-0dcda4401696 37 fields · synced May 30, 2026
- FDA UDI 4d89c6d0-613a-41c1-bd97-2bc157459ddb 37 fields · synced May 30, 2026
- FDA UDI 85afa62a-9849-45a0-8e7b-86b5722a95ee 37 fields · synced May 30, 2026
- FDA UDI a78b4238-5680-48d5-914f-3332ad168296 37 fields · synced May 30, 2026
- FDA UDI 2c91ce3e-33a4-499b-acd0-39c8cf85c7aa 37 fields · synced May 30, 2026
- FDA UDI c436532b-3e97-4c57-9149-b12baf23fee9 37 fields · synced May 30, 2026
- FDA UDI 5ec066d1-12de-4f2e-bfa6-a86058a9ba40 37 fields · synced May 30, 2026
- FDA UDI 8183fe95-97de-4027-87d0-2bd29e1411a5 37 fields · synced May 30, 2026
- FDA UDI 56a55135-dcbe-4673-ae86-132e91a89174 37 fields · synced May 30, 2026
- FDA UDI 48f41466-9e50-4ec4-aa84-6f04d2c7e88e 37 fields · synced May 30, 2026
- EUDAMED 7aa39dcf-75a3-4af6-b99f-37b858afc466 61 fields · synced Jul 9, 2026
- EUDAMED 77b54583-1150-45e8-a228-f6420c156aab 61 fields · synced Jul 9, 2026
- EUDAMED b9ae0d7f-19e0-4d3f-a438-0baae444bf95 61 fields · synced Jul 9, 2026
- EUDAMED b60e0eb3-2c77-471b-bf9d-51ad5847abc0 61 fields · synced Jul 9, 2026
- EUDAMED ea081bcf-ad0f-4e74-9cb8-2a5cc2077e5a 61 fields · synced Jul 10, 2026
- EUDAMED f9aa2358-0db7-43de-9d7e-264eab7ee12a 61 fields · synced Jul 11, 2026
- EUDAMED aff58524-4dce-42ff-9b72-ec095dc0c270 61 fields · synced Jul 11, 2026
- EUDAMED 5e1a6e25-11c6-4492-ba84-b62d9ccfe4ce 61 fields · synced Jul 14, 2026
- EUDAMED 3a33663b-f511-40fe-860c-ca69ee72b03e 61 fields · synced Jul 14, 2026
- EUDAMED 0357b4c8-7cd9-4457-9bb6-1daf0555d133 61 fields · synced Jul 15, 2026
- EUDAMED 9d819865-044c-4ce1-9790-6f39efb46287 61 fields · synced Jul 16, 2026
- EUDAMED 9e5cc2a8-d450-448d-8fb7-e2c586fc9af9 61 fields · synced Jul 24, 2026
- EUDAMED 3fcf65a8-d3ea-4f1a-bf64-d0fa518327ea 61 fields · synced Jul 24, 2026
- EUDAMED 7224fb32-071b-43cf-92a4-7383151b4b99 61 fields · synced Jul 27, 2026
- EUDAMED e3bcfb1a-35aa-4483-a4ed-f969f4f5552a 61 fields · synced Jul 29, 2026
- EUDAMED e26c74f0-b7f1-4acd-8075-21d42febf93a 61 fields · synced Jul 29, 2026