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Microlink

EUDAMEDFDA 510(k)FDA UDI

Class IIa (EU MDR)

Ref ASB-TPRef ASBR-KRef ASBNR-KRef ASBR-BB510(k) K190582Ref ASB-ME

by Conmed Corporation

Identity

Trade Name
MICROLINK EUDAMEDFDA UDI
Generic Name
Orthopaedic fixation suture button FDA UDI
Bone lever/elevator, reusable FDA UDI
Bone lever/elevator, single-use FDA UDI
Device Name
Orthopedic, Non-active, Instrument, MicroLink Trapezium Pin EUDAMED
Orthopedic, Implant, Non-absorbable, Suture Anchor, All Suture, Hand EUDAMED
Reusable Manual Surgical Instruments EUDAMED
MICROLINK, ALL-SUTURE BUTTON FIXATION SYSTEM (RADIOPAQUE) FDA UDI
MICROLINK, ALL-SUTURE BUTTON AND BACKSTOP (RADIOPAQUE) FDA UDI
MICROLINK, MCGLAMRY ELEVATOR FDA UDI
MICROLINK, ALL-SUTURE BUTTON FIXATION SYSTEM (RADIOLUCENT) FDA UDI
MICROLINK, CMC TRAPEZIUM PIN FDA UDI
Model / Reference
ASB-TP EUDAMEDFDA UDI
ASBR-K EUDAMEDFDA UDI
ASBNR-K EUDAMEDFDA UDI
ASBR-BB EUDAMEDFDA UDI
ASB-ME EUDAMEDFDA UDI
Description
MICROLINK, ALL-SUTURE BUTTON FIXATION SYSTEM (RADIOPAQUE) FDA UDI
MICROLINK, ALL-SUTURE BUTTON AND BACKSTOP (RADIOPAQUE) FDA UDI
MICROLINK, MCGLAMRY ELEVATOR FDA UDI
MICROLINK, ALL-SUTURE BUTTON FIXATION SYSTEM (RADIOLUCENT) FDA UDI
MICROLINK, CMC TRAPEZIUM PIN FDA UDI

Identifiers

Catalog Number
ASBR-K FDA UDI
ASBR-BB FDA UDI
ASB-ME FDA UDI
ASBNR-K FDA UDI
ASB-TP FDA UDI
Primary DI / UDI-DI
20845854600013 EUDAMEDFDA UDI
20845854648893 EUDAMEDFDA UDI
20845854648879 EUDAMEDFDA UDI
20845854648909 EUDAMEDFDA UDI
30845854049017 EUDAMEDFDA UDI
Basic UDI-DI
B-20845854600013 EUDAMED
B-20845854648893 EUDAMED
B-20845854648879 EUDAMED
B-20845854648909 EUDAMED
B-30845854049017 EUDAMED
510(k) Number
K190582 FDA 510(k)FDA UDI
K190516 FDA UDI
FDA Product Code
HTN FDA 510(k)FDA UDI
MDM FDA UDI
GFG FDA UDI
EMDN Code
P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
P09120102 ANCHORS, TENDON AND LIGAMENT SYNTHESIS EUDAMED
L0902 ORTHOPAEDIC SURGERY LEVERS, REUSABLE EUDAMED
GMDN Term
Orthopaedic fixation suture button FDA UDI
Bone lever/elevator, reusable FDA UDI
Bone lever/elevator, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class IIb EUDAMED
Class I EUDAMEDFDA UDI
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3030 FDA 510(k)
Regulation Number
888.3030 FDA 510(k)FDA UDI
878.4800 FDA UDI
878.4820 FDA UDI
Market of Registration
Belgium EUDAMED
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDIEUDAMEDFDA UDI

Single Use

Yes

FDA UDIFDA UDI

Implantable

No

EUDAMEDFDA UDIEUDAMEDFDA UDI

Reusable

No

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

No

FDA UDIFDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDIFDA UDI

Manufacturing Date

No

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

Category: Joint prosthesis implantation kit, single-use

Microlink by Conmed Corporation — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Conmed Corporation
EUDAMED SRN
US-MF-000012663
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (15)

  • EUDAMED af69c479-10c3-4f46-bbf2-277cdc6fd7bb 61 fields · synced Jul 27, 2026
  • EUDAMED 8d7c881a-6664-4723-a2da-c8c11c40ef2f 61 fields · synced May 17, 2026
  • EUDAMED c7e90b02-770d-4152-bca4-187afdfbbfe3 61 fields · synced May 17, 2026
  • EUDAMED 53661f30-f495-4ad0-a30c-146151f2c534 61 fields · synced May 18, 2026
  • FDA 510(k) K190582 24 fields · synced May 18, 2026
  • FDA UDI ee692e7d-74fc-4d2a-ae21-b04c9e3c0a35 37 fields · synced May 30, 2026
  • FDA UDI 33e48801-dd71-46f5-9e05-a159e486d7db 37 fields · synced May 30, 2026
  • FDA UDI df0f0454-d9f5-4592-957f-376507bc2723 37 fields · synced May 30, 2026
  • FDA UDI 6b3f9f54-821d-47f5-9d7b-081746608209 37 fields · synced May 30, 2026
  • FDA UDI b4e96279-cb07-4810-9730-efb497b681a3 36 fields · synced May 30, 2026
  • EUDAMED c2fbbc98-469d-424f-b676-eb01eee9337a 61 fields · synced Jul 11, 2026
  • EUDAMED c92105f4-f95a-473e-8e5b-ee5b0b313610 61 fields · synced Jul 13, 2026
  • EUDAMED 59b1b0a1-fc82-4cbf-b8d8-ab4e7669babe 61 fields · synced Jul 18, 2026
  • EUDAMED c9de4304-4cb8-4d77-bb29-8025ecff1e89 61 fields · synced Jul 19, 2026
  • EUDAMED 28b13c4e-c5ff-4082-a198-37fc266b006a 61 fields · synced Jul 27, 2026