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FFX ancillary
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 58.FXX.XXMRef 58.FXX.XXSRef 58.EXX.XXLRef 58.EXX.XXMRef 58.FXX.XXLRef 58.SGS.RIGHTRef 58.100.50SRef 58.EXX.XXSRef 58.100.HSCRef 57.003.00CRef 58.SGM.LEFTRef 58.Exx.xxS
by Sc Medica
Identity
- Device Name
- FFX ancillary EUDAMED
- Model / Reference
- 58.FXX.XXM EUDAMED58.FXX.XXS EUDAMED58.EXX.XXL EUDAMED58.EXX.XXM EUDAMED58.FXX.XXL EUDAMED58.SGS.RIGHT EUDAMED58.100.50S EUDAMED58.EXX.XXS EUDAMED58.100.HSC EUDAMED57.003.00C EUDAMED58.SGM.LEFT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770019503560 EUDAMED03770019503294 EUDAMED03770019503386 EUDAMED03770019503546 EUDAMED03770019503409 EUDAMED03770019503935 EUDAMED03770019503805 EUDAMED03770019503232 EUDAMED03770019503300 EUDAMED03770019503904 EUDAMED03770019503584 EUDAMED03770019503287 EUDAMED03770019503478 EUDAMED03770019503621 EUDAMED03760418040315 EUDAMED03760418040858 EUDAMED03770019503720 EUDAMED03770019503355 EUDAMED03770019503669 EUDAMED03770019503928 EUDAMED03760418041077 EUDAMED03770019503133 EUDAMED03770019503348 EUDAMED03770019503874 EUDAMED03770019503645 EUDAMED03770019503218 EUDAMED03770019503423 EUDAMED03770019503270 EUDAMED03770019503553 EUDAMED03770019503225 EUDAMED03760418040438 EUDAMED03770019503591 EUDAMED03760418040391 EUDAMED03770019503959 EUDAMED03770019503690 EUDAMED03760418040353 EUDAMED03760418040377 EUDAMED03760418040407 EUDAMED03760418040452 EUDAMED03770019503577 EUDAMED03770019503744 EUDAMED03770019503966 EUDAMED03770019503263 EUDAMED03770019503706 EUDAMED03770019503249 EUDAMED03770019503898 EUDAMED
- Basic UDI-DI
- 377001950357001DE EUDAMED
- Direct Marketing DI
- 03770019503560 EUDAMED03770019503294 EUDAMED03770019503386 EUDAMED03770019503546 EUDAMED03770019503409 EUDAMED03770019503935 EUDAMED03770019503805 EUDAMED03770019503232 EUDAMED03770019503300 EUDAMED03770019503904 EUDAMED03770019503584 EUDAMED03770019503287 EUDAMED03770019503478 EUDAMED03770019503621 EUDAMED03760418040315 EUDAMED03760418040858 EUDAMED03770019503720 EUDAMED03770019503355 EUDAMED03770019503669 EUDAMED03770019503928 EUDAMED03760418041077 EUDAMED03770019503133 EUDAMED03770019503348 EUDAMED03770019503874 EUDAMED03770019503645 EUDAMED03770019503218 EUDAMED03770019503423 EUDAMED03770019503270 EUDAMED03770019503553 EUDAMED03770019503225 EUDAMED03760418040438 EUDAMED03770019503591 EUDAMED03760418040391 EUDAMED03770019503959 EUDAMED03770019503690 EUDAMED03760418040353 EUDAMED03760418040377 EUDAMED03760418040407 EUDAMED03760418040452 EUDAMED03770019503577 EUDAMED03770019503744 EUDAMED03770019503966 EUDAMED03770019503263 EUDAMED03770019503706 EUDAMED03770019503249 EUDAMED03770019503898 EUDAMED
- EMDN Code
- Z12130503 ORTHOPAEDIC SURGICAL DRILLS EUDAMEDL26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMEDL098099 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES EUDAMEDL091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMEDL091201 ORTHOPAEDIC SURGERY RASPS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
FFX ancillary by Sc Medica — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232468 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 377001950357001DE | Class I | Active |
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Manufacturer
- Manufacturer
- Sc Medica
- EUDAMED SRN
- FR-MF-000002722
Sources (47)
- EUDAMED b1bed487-a73e-4e63-9804-3ad6d24fff64 61 fields · synced Sep 18, 2026
- EUDAMED 02603302-2b18-4204-840f-5f0ed7d9e5a9 61 fields · synced May 11, 2026
- EUDAMED 18a6635a-beaa-4241-b65e-b405e895da51 61 fields · synced May 11, 2026
- EUDAMED 61f85058-a567-438d-b43a-1aef4a0731a8 61 fields · synced May 16, 2026
- EUDAMED a2ff8507-a313-4194-92a9-a24d99934357 61 fields · synced May 16, 2026
- EUDAMED c81d1105-06d3-45ff-925d-6b6b99c0c148 61 fields · synced May 16, 2026
- EUDAMED 3adf9ef9-361f-410a-ac34-07f477d0d590 61 fields · synced May 16, 2026
- EUDAMED 6e229f87-5b54-44f9-af11-1c5ea91322a8 61 fields · synced May 17, 2026
- EUDAMED 993c1606-4be0-40ba-aa2b-c718b74ffc2a 61 fields · synced May 17, 2026
- EUDAMED 4e614431-5141-4f7b-967d-1659078f073f 61 fields · synced May 17, 2026
- EUDAMED f4006854-b910-4851-b408-f766b70756e3 61 fields · synced May 17, 2026
- EUDAMED bf8beeab-1757-4689-aaa2-0508fb626c92 61 fields · synced May 17, 2026
- EUDAMED b5244167-4872-4d31-835c-c8f46986c2a9 61 fields · synced May 17, 2026
- EUDAMED b03da113-cb76-4727-9432-04a1fd8db984 61 fields · synced May 17, 2026
- EUDAMED 010f053b-53f1-47bf-a173-572b71569fa3 61 fields · synced May 17, 2026
- EUDAMED b016dbd0-eeeb-465e-88a1-9e80a6fd6aab 61 fields · synced May 17, 2026
- EUDAMED 727f6f73-895d-493e-9fa2-b489c8a0c0b1 61 fields · synced May 17, 2026
- EUDAMED 45ed2cfd-c627-4f8b-a294-0bd682fedc73 61 fields · synced May 17, 2026
- EUDAMED bad34958-6bc9-4143-951e-7006e6f9d353 61 fields · synced May 17, 2026
- EUDAMED ca280a0d-5c58-40b9-9b5b-c526821c4757 61 fields · synced May 17, 2026
- EUDAMED 117263e7-3e05-4267-910a-2d7707956494 61 fields · synced May 18, 2026
- EUDAMED 4b800be3-c65c-4173-875e-9aa6e66ecb61 61 fields · synced May 18, 2026
- EUDAMED 126b3645-1d68-4105-a014-fb847a46b187 61 fields · synced May 18, 2026
- EUDAMED 583b8f9a-eaae-4aa0-bd18-beb140215901 61 fields · synced May 18, 2026
- EUDAMED 19757bdd-8603-4c25-98bb-c1b05ea328a8 61 fields · synced May 18, 2026
- EUDAMED f98e1b62-cb12-44ca-aec5-c855ea1808c1 61 fields · synced May 19, 2026
- EUDAMED e201b3d0-8dd5-4508-b382-a883502ab879 61 fields · synced May 19, 2026
- EUDAMED fc6dbd84-2f32-4692-8ebc-405e69af3760 61 fields · synced May 19, 2026
- EUDAMED 813c68cb-79b7-407e-a886-8402fd1975be 61 fields · synced May 19, 2026
- EUDAMED 0347e5a9-45d6-4357-bbcb-4289cfba36b1 61 fields · synced May 19, 2026
- EUDAMED f6a86cb6-313a-42f5-8bc7-1f1292097775 61 fields · synced May 19, 2026
- EUDAMED 86eab104-233b-4d1c-8ce5-c1e648a44253 61 fields · synced May 19, 2026
- EUDAMED a93f4b99-1980-40b4-ac5e-8052835fec90 61 fields · synced May 19, 2026
- EUDAMED 9a9499df-ae52-462e-9ff4-b8416030b1bd 61 fields · synced May 19, 2026
- EUDAMED b659cac8-dc9e-4fce-b0c4-6db2c2a2bd2d 61 fields · synced May 19, 2026
- EUDAMED 951559b5-22a3-4290-b2fb-51bf7b54fc15 61 fields · synced May 19, 2026
- EUDAMED 747db6ed-cc64-4993-9cfd-80fceb24083d 61 fields · synced May 19, 2026
- EUDAMED f8a666f9-1c91-471f-b122-9a8f55899306 61 fields · synced May 19, 2026
- EUDAMED 67b655b5-99de-4854-8dd6-8d9b0b8a8a8e 61 fields · synced May 19, 2026
- EUDAMED 279eb662-5d76-4b81-a5cb-66942e30b11d 61 fields · synced May 19, 2026
- EUDAMED 719e0940-bc33-4f66-bd44-d52b77feccd6 61 fields · synced May 19, 2026
- EUDAMED c027b829-4b60-4f14-935a-3cd3f05c3b6c 61 fields · synced May 19, 2026
- EUDAMED ac489731-437c-4086-9ca7-7ba7211eed65 61 fields · synced May 19, 2026
- EUDAMED d869de14-6e90-4003-8723-46fb8d8fe72a 61 fields · synced May 19, 2026
- EUDAMED a2cfafe7-b1df-4f5a-a7d2-573aa072559c 61 fields · synced May 19, 2026
- EUDAMED 3baab1f5-46fc-4558-a08e-0939f1b9c2ee 61 fields · synced May 19, 2026
- FDA 510(k) K232468 1 fields · synced May 18, 2026