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CoLink

EUDAMEDFDA UDI

Class I (EU MDR)

Ref P04 N0071Ref P04 209A00Ref P09 N1016Ref P09 N1013Ref P07 201A00Ref P09 N1205Ref P04 N0011Ref P04 N0052Ref P09 N1105Ref P09 N1025Ref P40 ST238Ref P09 N1018Ref P04 N0081Ref P09 N1014Ref P04 N0361Ref P09 N1012Ref P04 N0432Ref P04 N0331Ref P04 N0051Ref P02 202A00

by In2Bones, USA

Identity

Trade Name
CoLink EUDAMEDFDA UDI
CoLink Mini EUDAMEDFDA UDI
Generic Name
Orthopaedic implant driver FDA UDI
Surgical implant template, reusable FDA UDI
Orthopaedic fixation implant alignment tool FDA UDI
Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Surgical drill guide, reusable FDA UDI
Instrument tray, reusable FDA UDI
Orthopaedic bur, reusable FDA UDI
Device Name
Non-patient-contacting Class I instruments, Non-Active EUDAMED
Mini Plates Non-sterile Instruments, Active EUDAMED
CoLink Plating System EUDAMED
T8 DRIVER BIT, NON-STERILE FDA UDI
Straight Plate, 8H, Trial FDA UDI
LOCKING DRILL GUIDE, 2.0 MM, NON-STERILE FDA UDI
CoLink MTP Plate NX, 6-Hole, Left FDA UDI
Straight Plate, 6H, Trial FDA UDI
Tranverse Drill Guide Assembly, 3.0 Screw FDA UDI
T-Plate, 7H, Trial FDA UDI
COLINK 2 H-PLATE TRIAL, SMALL, NON-STERILE FDA UDI
Straight Plate, 3H, Trial FDA UDI
T8 DRIVER, AO CONNECT-FRANCE, NON-STERILE FDA UDI
Non-Locking Drill Guide, Assy FDA UDI
Straight Plate, 4H, Trial FDA UDI
Straight Plate, 2H, Trial FDA UDI
COLINK 2 MTP PLATE TRIAL,NX,NARROW,0°DF,6H,LEFT,NON-STERLE FDA UDI
Oblique L Plate, 5H, Left, Trial FDA UDI
Oblique L Plate, 5H, Right, Trial FDA UDI
CoLink® NeoFuse MIS Plating System, Instrument Tray FDA UDI
COLINK 2.0 X 60 MM DRILL, NON-STERILE FDA UDI
Model / Reference
P04 N0071 EUDAMEDFDA UDI
P04 209A00 EUDAMED
P09 N1016 EUDAMEDFDA UDI
P09 N1013 EUDAMEDFDA UDI
P07 201A00 EUDAMED
P09 N1205 EUDAMEDFDA UDI
P04 N0011 EUDAMEDFDA UDI
P04 N0052 EUDAMEDFDA UDI
P09 N1105 EUDAMEDFDA UDI
P09 N1025 EUDAMEDFDA UDI
P40 ST238 EUDAMEDFDA UDI
P09 N1018 EUDAMEDFDA UDI
P04 N0081 EUDAMEDFDA UDI
P09 N1014 EUDAMEDFDA UDI
P04 N0361 EUDAMEDFDA UDI
P09 N1012 EUDAMEDFDA UDI
P04 N0432 EUDAMEDFDA UDI
P04 N0331 EUDAMEDFDA UDI
P04 N0051 EUDAMEDFDA UDI
P02 202A00 EUDAMEDFDA UDI
Description
T8 DRIVER BIT, NON-STERILE FDA UDI
Straight Plate, 8H, Trial FDA UDI
LOCKING DRILL GUIDE, 2.0 MM, NON-STERILE FDA UDI
CoLink MTP Plate NX, 6-Hole, Left FDA UDI
Straight Plate, 6H, Trial FDA UDI
Tranverse Drill Guide Assembly, 3.0 Screw FDA UDI
T-Plate, 7H, Trial FDA UDI
COLINK 2 H-PLATE TRIAL, SMALL, NON-STERILE FDA UDI
Straight Plate, 3H, Trial FDA UDI
T8 DRIVER, AO CONNECT-FRANCE, NON-STERILE FDA UDI
Non-Locking Drill Guide, Assy FDA UDI
Straight Plate, 4H, Trial FDA UDI
Straight Plate, 2H, Trial FDA UDI
COLINK 2 MTP PLATE TRIAL,NX,NARROW,0°DF,6H,LEFT,NON-STERLE FDA UDI
Oblique L Plate, 5H, Left, Trial FDA UDI
Oblique L Plate, 5H, Right, Trial FDA UDI
CoLink® NeoFuse MIS Plating System, Instrument Tray FDA UDI
COLINK 2.0 X 60 MM DRILL, NON-STERILE FDA UDI

Identifiers

Catalog Number
P04 N0051 FDA UDI
P09 N1018 FDA UDI
P04 N0011 FDA UDI
P40 ST238 FDA UDI
P09 N1016 FDA UDI
P04 N0081 FDA UDI
P09 N1025 FDA UDI
P04 N0361 FDA UDI
P09 N1013 FDA UDI
P04 N0052 FDA UDI
P04 N0071 FDA UDI
P09 N1014 FDA UDI
P09 N1012 FDA UDI
P04 N0432 FDA UDI
P09 N1205 FDA UDI
P09 N1105 FDA UDI
P02 202A00 FDA UDI
P04 N0331 FDA UDI
Primary DI / UDI-DI
00810021861098 EUDAMEDFDA UDI
00810021866635 EUDAMED
00817906029543 EUDAMEDFDA UDI
00817906029529 EUDAMEDFDA UDI
00810021866994 EUDAMED
00817906029482 EUDAMEDFDA UDI
00817906027914 EUDAMEDFDA UDI
00817906029628 EUDAMEDFDA UDI
00817906029475 EUDAMEDFDA UDI
00817906029574 EUDAMEDFDA UDI
00817906024333 EUDAMEDFDA UDI
00817906029550 EUDAMEDFDA UDI
00817906027938 EUDAMEDFDA UDI
00817906029536 EUDAMEDFDA UDI
00810021864969 EUDAMEDFDA UDI
00817906029512 EUDAMEDFDA UDI
00810021864129 EUDAMEDFDA UDI
00810021863757 EUDAMEDFDA UDI
00817906029611 EUDAMEDFDA UDI
00850066074046 EUDAMEDFDA UDI
Basic UDI-DI
08101755051447 EUDAMED
08101755028147 EUDAMED
0810175502674D EUDAMED
B-00817906024333 EUDAMED
081002186100YL EUDAMED
510(k) Number
K163293 FDA UDI
K201149 FDA UDI
K213069 FDA UDI
FDA Product Code
LXH FDA UDI
HWT FDA UDI
HWC FDA UDI
HRS FDA UDI
FZX FDA UDI
FSM FDA UDI
EMDN Code
L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
V0480 CLINICAL USE CONTAINERS (NON-IVD) - ACCESSORIES EUDAMED
L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
P09120699 BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER EUDAMED
GMDN Term
Orthopaedic implant driver FDA UDI
Surgical implant template, reusable FDA UDI
Orthopaedic fixation implant alignment tool FDA UDI
Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Surgical drill guide, reusable FDA UDI
Instrument tray, reusable FDA UDI
Orthopaedic bur, reusable FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Class IIa EUDAMED
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
888.4540 FDA UDI
888.4800 FDA UDI
888.3040 FDA UDI
888.3030 FDA UDI
878.4800 FDA UDI
Market of Registration
Belgium EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDIEUDAMEDFDA UDI

Single Use

No

FDA UDIFDA UDI

Implantable

No

EUDAMEDFDA UDIEUDAMEDFDA UDI

Reusable

Yes

EUDAMEDEUDAMED

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

No

FDA UDIFDA UDI

Manufacturing Date

Yes

FDA UDIFDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

CoLink by In2Bones, USA — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

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 (56)

  • EUDAMED 52efef02-aa59-456c-bc77-4f5c2ef7c000 61 fields · synced Sep 18, 2026
  • EUDAMED 79af7f4d-108a-4c58-a3dc-d6860b3fbf8b 61 fields · synced May 11, 2026
  • EUDAMED c1bc2c58-f3b4-4c7d-a7bd-09f685d4c7ac 61 fields · synced May 11, 2026
  • EUDAMED bb00a33b-64c2-479b-b15e-b21893025149 61 fields · synced May 16, 2026
  • EUDAMED 75a93b58-d390-45e8-8b4e-aae59e094879 61 fields · synced May 17, 2026
  • EUDAMED cf44208c-6654-421c-a8ad-b3ab911685e2 61 fields · synced May 17, 2026
  • EUDAMED e42b9629-be3a-45ac-ba20-4a212ad60c23 61 fields · synced May 17, 2026
  • EUDAMED 3bfb34b4-f0d8-4cf3-bfc6-6e7214cc55e0 61 fields · synced May 17, 2026
  • EUDAMED 51592c39-c482-4860-8eb2-5290c862c14c 61 fields · synced May 17, 2026
  • EUDAMED 6efbea3e-275d-437e-8d27-ff5ff2009b95 61 fields · synced May 17, 2026
  • EUDAMED 1f322be8-9d97-4022-a237-2f405a088df2 61 fields · synced May 17, 2026
  • EUDAMED 9bc8d157-367f-4d0f-a915-e10578fc3915 61 fields · synced May 17, 2026
  • EUDAMED 6f16aaca-f7bd-4bc0-956a-eedc8bd72764 61 fields · synced May 17, 2026
  • EUDAMED 6825c2a3-dfd0-4119-b165-34187fb9f4c1 61 fields · synced May 17, 2026
  • EUDAMED 7cd7eb03-f93f-4314-8cde-8fe7651c7b87 61 fields · synced May 18, 2026
  • EUDAMED b90b147d-e931-45c1-8078-6a01beb59e30 61 fields · synced May 18, 2026
  • EUDAMED 5027a399-c53e-49ae-8dcb-0b8f19d9dc3a 61 fields · synced May 18, 2026
  • EUDAMED 1bade281-a849-4d78-8f00-80b5e017ac0b 61 fields · synced May 18, 2026
  • FDA UDI 3ce69db0-14f2-4560-90a6-aa96e354479e 35 fields · synced May 26, 2026
  • FDA UDI e737f139-d694-4021-a578-e2555d799736 35 fields · synced May 27, 2026
  • FDA UDI 6744b3e2-20fd-434c-8f2c-8d4c585eaf86 36 fields · synced May 27, 2026
  • FDA UDI 8e9e7d71-9251-4e49-9a31-7e2a5bcf2cd0 36 fields · synced May 29, 2026
  • FDA UDI 30391f82-2b9d-45d3-8cd5-1449714eff27 35 fields · synced May 30, 2026
  • FDA UDI 2d5a043a-1775-420c-b45d-75da72b32b5d 36 fields · synced May 30, 2026
  • FDA UDI 2f8989fe-141f-4ef3-8af2-e30b7bc51986 35 fields · synced May 30, 2026
  • FDA UDI 7f61706d-e0f9-4599-b507-994b57179232 36 fields · synced May 30, 2026
  • FDA UDI bab97e62-81db-42dc-aab3-f652430d157a 35 fields · synced May 30, 2026
  • FDA UDI ef926c74-ac3e-4754-92da-f45ef6664ddb 35 fields · synced May 30, 2026
  • FDA UDI e7e5041d-dee5-4bfa-9e8d-24af58d27e67 35 fields · synced May 30, 2026
  • FDA UDI 67ece8e0-f1b6-4274-8453-5ebbc9008055 35 fields · synced May 30, 2026
  • FDA UDI e896d9fe-1fa3-4e7f-a93d-82ff3fe9b3db 35 fields · synced May 30, 2026
  • FDA UDI bce4e311-c01f-47f7-86f6-135a341aeb3a 36 fields · synced May 30, 2026
  • FDA UDI 5bbcec27-ad39-496f-8bec-2fca7017b8bd 35 fields · synced May 30, 2026
  • FDA UDI e42ce8b4-30cb-4aff-b071-5b08b051c362 35 fields · synced May 30, 2026
  • FDA UDI 691a722d-3d70-4e63-980f-d3a0b8c1a535 36 fields · synced May 30, 2026
  • FDA UDI d31cf1ba-d191-4283-ad21-208b82078887 36 fields · synced May 30, 2026
  • EUDAMED ee8a3617-3ce4-4e97-b42e-0722a9875b03 61 fields · synced Jul 8, 2026
  • EUDAMED c27e6822-8f49-490e-a542-8a850b1eacf5 61 fields · synced Jul 9, 2026
  • EUDAMED 91f63f0b-6537-443f-b729-ab8d80a45787 61 fields · synced Jul 9, 2026
  • EUDAMED 017faf9b-5b77-41c5-b724-2f1852dddcc4 61 fields · synced Jul 9, 2026
  • EUDAMED ec32f7d2-78b0-47bc-8b1d-b731a5bd682c 61 fields · synced Jul 9, 2026
  • EUDAMED e9f61008-b98d-40b4-8fb6-1107b3c12507 61 fields · synced Jul 9, 2026
  • EUDAMED caf3b23b-5e30-4d7d-8818-b54c4abe4d0a 61 fields · synced Jul 10, 2026
  • EUDAMED 0aafe49d-4190-4362-9522-8f3f16080576 61 fields · synced Jul 10, 2026
  • EUDAMED eeddc40d-2baa-4e4f-9a9b-21e8a0daf4cb 61 fields · synced Jul 11, 2026
  • EUDAMED 4db14b5a-a8f1-49ce-bd8b-1d9e3ef7c588 61 fields · synced Jul 14, 2026
  • EUDAMED 54565e1d-4236-418d-bcd6-390a5a3b8619 61 fields · synced Jul 14, 2026
  • EUDAMED 871e8938-7914-4b3c-9ae1-832a8cd6021c 61 fields · synced Jul 18, 2026
  • EUDAMED a742c87c-4096-41e6-96c2-a3c50cd419fe 61 fields · synced Jul 23, 2026
  • EUDAMED efae3a11-c2ad-45e0-b182-ae473c8693c1 61 fields · synced Jul 23, 2026
  • EUDAMED febeded8-3737-4a1d-883d-0012b27989a2 61 fields · synced Jul 24, 2026
  • EUDAMED 06e4729e-4970-4499-aea4-48ea6e2edc05 61 fields · synced Jul 26, 2026
  • EUDAMED 8a0c2ac8-d68c-47b6-8180-be57b900da69 61 fields · synced Jul 26, 2026
  • EUDAMED 118cfddc-6d25-4387-b59b-c2e0dd632563 61 fields · synced Jul 30, 2026
  • EUDAMED 5247a710-d5d9-4e87-9eae-26c147aa8a26 61 fields · synced Sep 17, 2026
  • EUDAMED 2487a44c-70ca-444a-817a-7d3f0ed2701f 61 fields · synced Sep 18, 2026