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CoLink Afx

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref P07 S0001Ref P07 N1207Ref P07 N1504Ref P07 N1110Ref P07 N1303Ref P07 N1307Ref P07 N1108Ref P07 N1304Ref P07 N1202Ref P07 N1103Ref P07 N1201Ref P07 N1105Ref P07 N1503Ref P07 N1203Ref P07 N1502Ref P07 N1011Ref P07 N1308Ref P07 N1310

by In2Bones, USA

Identity

Trade Name
CoLink Afx EUDAMEDFDA UDI
Generic Name
Surgical implant/trial-implant/sizer holder, reusable FDA UDI
General internal orthopaedic fixation system implantation kit FDA UDI
Device Name
Ankle Fracture Sterile Instruments, Active EUDAMED
Ankle Fracture Non-Sterile Instruments (Trials), Active EUDAMED
POSTEROLATERAL FIBULA PLATE, 4-HOLE, LEFT, TRIAL FDA UDI
POSTEROLATERAL FIBULA PLATE, 4-HOLE, RIGHT, TRIAL FDA UDI
POSTEROLATERAL FIBULA PLATE, 6-HOLE, RIGHT, TRIAL FDA UDI
ONE-THIRD TUBULAR PLATE, 3-HOLE, TRIAL FDA UDI
ONE-THIRD TUBULAR PLATE, 4-HOLE, TRIAL FDA UDI
POSTEROLATERAL FIBULA PLATE, 6-HOLE, LEFT, TRIAL FDA UDI
POSTERIOR TIBIA PLATE, 5-HOLE, LEFT, TRIAL FDA UDI
ONE-THIRD TUBULAR PLATE, 12-HOLE, TRIAL FDA UDI
LATERAL FIBULA PLATE, 4-HOLE, LEFT, TRIAL FDA UDI
LATERAL FIBULA PLATE, 5-HOLE, LEFT, TRIAL FDA UDI
LATERAL FIBULA PLATE, 3-HOLE, LEFT, TRIAL FDA UDI
CoLink Afx Sterile Single Use Instrument Kit FDA UDI
POSTERIOR TIBIA PLATE, 3-HOLE, RIGHT, TRIAL FDA UDI
LATERAL FIBULA PLATE, 9-HOLE, RIGHT, TRIAL FDA UDI
LATERAL FIBULA PLATE, 7-HOLE, RIGHT, TRIAL FDA UDI
POSTEROLATERAL FIBULA PLATE, 7-HOLE, RIGHT, TRIAL FDA UDI
ONE-THIRD TUBULAR PLATE, 5-HOLE, TRIAL FDA UDI
POSTERIOR TIBIA PLATE, 5-HOLE, RIGHT, TRIAL FDA UDI
Model / Reference
P07 S0001 EUDAMEDFDA UDI
P07 N1207 EUDAMEDFDA UDI
P07 N1504 EUDAMEDFDA UDI
P07 N1110 EUDAMEDFDA UDI
P07 N1303 EUDAMEDFDA UDI
P07 N1307 EUDAMEDFDA UDI
P07 N1108 EUDAMEDFDA UDI
P07 N1304 EUDAMEDFDA UDI
P07 N1202 EUDAMEDFDA UDI
P07 N1103 EUDAMEDFDA UDI
P07 N1201 EUDAMEDFDA UDI
P07 N1105 EUDAMEDFDA UDI
P07 N1503 EUDAMEDFDA UDI
P07 N1203 EUDAMEDFDA UDI
P07 N1502 EUDAMEDFDA UDI
P07 N1011 EUDAMEDFDA UDI
P07 N1308 EUDAMEDFDA UDI
P07 N1310 EUDAMEDFDA UDI
Description
POSTEROLATERAL FIBULA PLATE, 4-HOLE, LEFT, TRIAL FDA UDI
POSTEROLATERAL FIBULA PLATE, 4-HOLE, RIGHT, TRIAL FDA UDI
POSTEROLATERAL FIBULA PLATE, 6-HOLE, RIGHT, TRIAL FDA UDI
ONE-THIRD TUBULAR PLATE, 3-HOLE, TRIAL FDA UDI
ONE-THIRD TUBULAR PLATE, 4-HOLE, TRIAL FDA UDI
POSTEROLATERAL FIBULA PLATE, 6-HOLE, LEFT, TRIAL FDA UDI
POSTERIOR TIBIA PLATE, 5-HOLE, LEFT, TRIAL FDA UDI
ONE-THIRD TUBULAR PLATE, 12-HOLE, TRIAL FDA UDI
LATERAL FIBULA PLATE, 4-HOLE, LEFT, TRIAL FDA UDI
LATERAL FIBULA PLATE, 5-HOLE, LEFT, TRIAL FDA UDI
LATERAL FIBULA PLATE, 3-HOLE, LEFT, TRIAL FDA UDI
CoLink Afx Sterile Single Use Instrument Kit FDA UDI
POSTERIOR TIBIA PLATE, 3-HOLE, RIGHT, TRIAL FDA UDI
LATERAL FIBULA PLATE, 9-HOLE, RIGHT, TRIAL FDA UDI
LATERAL FIBULA PLATE, 7-HOLE, RIGHT, TRIAL FDA UDI
POSTEROLATERAL FIBULA PLATE, 7-HOLE, RIGHT, TRIAL FDA UDI
ONE-THIRD TUBULAR PLATE, 5-HOLE, TRIAL FDA UDI
POSTERIOR TIBIA PLATE, 5-HOLE, RIGHT, TRIAL FDA UDI

Identifiers

Catalog Number
P07 N1303 FDA UDI
P07 N1304 FDA UDI
P07 N1308 FDA UDI
P07 N1201 FDA UDI
P07 N1202 FDA UDI
P07 N1307 FDA UDI
P07 N1503 FDA UDI
P07 N1207 FDA UDI
P07 N1103 FDA UDI
P07 N1105 FDA UDI
P07 N1011 FDA UDI
P07 S0001 FDA UDI
P07 N1502 FDA UDI
P07 N1110 FDA UDI
P07 N1108 FDA UDI
P07 N1310 FDA UDI
P07 N1203 FDA UDI
P07 N1504 FDA UDI
Primary DI / UDI-DI
00810021864242 EUDAMEDFDA UDI
00817906028546 EUDAMEDFDA UDI
00817906028706 EUDAMEDFDA UDI
00817906028430 EUDAMEDFDA UDI
00817906028577 EUDAMEDFDA UDI
00817906028614 EUDAMEDFDA UDI
00817906028416 EUDAMEDFDA UDI
00817906028584 EUDAMEDFDA UDI
00817906028492 EUDAMEDFDA UDI
00817906028362 EUDAMEDFDA UDI
00817906028485 EUDAMEDFDA UDI
00817906028386 EUDAMEDFDA UDI
00817906028690 EUDAMEDFDA UDI
00817906028508 EUDAMEDFDA UDI
00817906028683 EUDAMEDFDA UDI
00817906028348 EUDAMEDFDA UDI
00817906028621 EUDAMEDFDA UDI
00817906028645 EUDAMEDFDA UDI
Basic UDI-DI
0810175502523Y EUDAMED
08101755025342 EUDAMED
510(k) Number
K181113 FDA UDI
FDA Product Code
HWC FDA UDI
HRS FDA UDI
LXH FDA UDI
EMDN Code
P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
GMDN Term
Surgical implant/trial-implant/sizer holder, reusable FDA UDI
General internal orthopaedic fixation system implantation kit FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Class I FDA UDI
Regulation Number
888.3040 FDA UDI
888.3030 FDA UDI
888.4540 FDA UDI
Market of Registration
Belgium EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDIEUDAMEDFDA UDI

Single Use

No

FDA UDIFDA 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 UDIFDA 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

No

FDA UDIFDA UDI

Manufacturing Date

Yes

FDA UDIFDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Joint prosthesis implantation kit, single-use

CoLink Afx by In2Bones, USA — Class IIa — MDR, 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/MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
In2Bones, USA
EUDAMED SRN
US-MF-000023092
Authorised Representative
Conmed Europe BV BE-AR-000035662

Sources (53)

  • EUDAMED 8a9d5d7b-b6c2-484e-adfd-13a179460d1b 61 fields · synced Aug 2, 2026
  • EUDAMED d9f9a879-4f95-489e-b760-6f415cfcea5f 61 fields · synced May 16, 2026
  • EUDAMED c09bbeee-3c39-492b-ad4e-3a266a62c2e0 61 fields · synced May 17, 2026
  • EUDAMED 594cf4be-2dea-43da-9b6c-5b427b367665 61 fields · synced May 17, 2026
  • EUDAMED 3a709940-04cf-4e55-92cb-cb3b61e53244 61 fields · synced May 17, 2026
  • EUDAMED e0609a58-a43d-48b4-a7dd-1c0c98275a76 61 fields · synced May 17, 2026
  • EUDAMED af015fb0-9d1b-4923-8279-f5e6b7d0f939 61 fields · synced May 17, 2026
  • EUDAMED 6852bb41-2357-42ad-8fa1-c029ae7f412c 61 fields · synced May 18, 2026
  • EUDAMED c5e853af-ffd6-4c05-bdfe-217b74fe646e 61 fields · synced May 18, 2026
  • EUDAMED 93eeb471-712b-4d3d-b29d-86455acb3b60 61 fields · synced May 18, 2026
  • EUDAMED 9f427236-e374-41fc-8b0e-e1c52b8fdab0 61 fields · synced May 18, 2026
  • EUDAMED 4ab9f751-d73f-4a03-9bda-d2c08d1af192 61 fields · synced May 18, 2026
  • EUDAMED 14bb20aa-02d4-477c-947a-ea8376247582 61 fields · synced May 18, 2026
  • EUDAMED 11d94f35-2155-4cbd-80a4-cf81ec6ae987 61 fields · synced May 18, 2026
  • EUDAMED 45a35028-ffe6-4743-90e1-b86aa5e22f1a 61 fields · synced May 18, 2026
  • EUDAMED c9d4e806-5652-45ab-af17-158bff6a5b94 61 fields · synced May 18, 2026
  • EUDAMED 585215e2-ac93-4812-bed4-b1df6d8ff6b8 61 fields · synced May 18, 2026
  • FDA UDI d0632ede-d771-44c0-848e-bcc295f4909f 36 fields · synced May 29, 2026
  • FDA UDI cb25b144-0eeb-485d-8014-1560267f9210 36 fields · synced May 30, 2026
  • FDA UDI 24e2adc0-1efc-4567-a8a6-522b6eadd406 36 fields · synced May 30, 2026
  • FDA UDI 1c4d24f8-df0c-4e3c-814b-8ce9504a4528 36 fields · synced May 30, 2026
  • FDA UDI ccce872b-bbc7-42fe-baa6-daee907d216d 36 fields · synced May 30, 2026
  • FDA UDI 7d79fd50-5bfd-47ea-9d91-667eef997f27 36 fields · synced May 30, 2026
  • FDA UDI 1f886dfb-0691-43fb-af08-93570727f2a8 36 fields · synced May 30, 2026
  • FDA UDI 3080fb5f-4e50-4fd1-8809-a39f6a26a9ef 36 fields · synced May 30, 2026
  • FDA UDI 5adf82d0-0bcc-4976-8b4f-edcfc30a05e3 36 fields · synced May 30, 2026
  • FDA UDI eef7ee93-3ea3-4fdc-bc2c-85a8dceb0b3e 36 fields · synced May 30, 2026
  • FDA UDI 98cf6c23-f3c3-4bbb-98ed-a2f6e3c824fa 36 fields · synced May 30, 2026
  • FDA UDI 193e5311-f02d-4fbe-884c-91431ba73a10 36 fields · synced May 30, 2026
  • FDA UDI 706bcff8-7801-42c2-aff5-50840bfd962b 36 fields · synced May 30, 2026
  • FDA UDI a85f1037-f5c7-4bac-94a4-31a25957206c 36 fields · synced May 30, 2026
  • FDA UDI 994d4dbd-cf26-416e-9db9-aa023b894532 36 fields · synced May 30, 2026
  • FDA UDI 093805b4-3a41-494e-9802-530e3db48626 36 fields · synced May 30, 2026
  • FDA UDI e424ff77-fcd3-467d-84a9-770fe7e7adfd 36 fields · synced May 30, 2026
  • FDA UDI aa70bf20-1206-43d5-9213-e5a3fbb1ebcd 36 fields · synced May 30, 2026
  • EUDAMED e1f2cdbe-b967-40dc-be1e-2c22f683091e 61 fields · synced Jul 8, 2026
  • EUDAMED 8f432c44-1133-4e13-a0a4-ea7cf7f2ccc9 61 fields · synced Jul 10, 2026
  • EUDAMED 9d29874d-552b-4594-b9a8-e7be73d5d6b0 61 fields · synced Jul 10, 2026
  • EUDAMED 0a6b72be-03fe-4737-98b3-a0ad152ac4c3 61 fields · synced Jul 12, 2026
  • EUDAMED dcde77ac-fee8-4a0a-9f9d-add383e43584 61 fields · synced Jul 13, 2026
  • EUDAMED 25710fb9-a6ef-4193-aea2-4a4410118a41 61 fields · synced Jul 14, 2026
  • EUDAMED ade7aac4-abc5-44ac-81cb-86509b1687bc 61 fields · synced Jul 14, 2026
  • EUDAMED fbe837f2-5d3d-4593-81b0-b6345bf8b217 61 fields · synced Jul 17, 2026
  • EUDAMED 63517bd6-42a6-470b-bc8d-875ef38d3147 61 fields · synced Jul 17, 2026
  • EUDAMED e6d2cc67-53a7-44c5-b703-4c6edefb0a65 61 fields · synced Jul 19, 2026
  • EUDAMED b486dc53-d5c9-45fe-9491-48bd727fbc21 61 fields · synced Jul 24, 2026
  • EUDAMED e0622ff2-288d-42db-a0e2-f7bc8ad214cc 61 fields · synced Jul 25, 2026
  • EUDAMED f7bd9e98-25c3-41dc-8c2c-94a94e0f55cd 61 fields · synced Jul 27, 2026
  • EUDAMED 680388fe-a3d7-481d-bbcd-c4bfa7f3966e 61 fields · synced Jul 27, 2026
  • EUDAMED 1b4a8f3d-b97d-49d0-a431-fdecdb408641 61 fields · synced Jul 28, 2026
  • EUDAMED 28e0b08b-b3d3-40d9-95e0-d6f826280e91 61 fields · synced Jul 28, 2026
  • EUDAMED 7f57306d-983c-432c-9fa9-70781073cbba 61 fields · synced Jul 31, 2026
  • EUDAMED 2398f249-03a4-4b53-a4e4-00a0b99bb8c8 61 fields · synced Aug 2, 2026