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CoLink® P73 ST412

by Conmed Corporation

CoLink P73 ST412 is a medical device (FDA Class II; FDA product code HWC, Screw, fixation, bone) made by Conmed Corporation, cleared under FDA 510(k) K181113 on 15 Jun 2018 and listed in FDA GUDID since 3 Jul 2025 (UDI-DI 00810021867403), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K181113

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810021867403 UDI-DI Date3 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK181113 Date15 Jun 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K181113 decided 15 Jun 2018 Active
  • FDA GUDID UDI-DI 00810021867403 listed 3 Jul 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K181113
  2. Listed FDA GUDID 00810021867403

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CoLink®
Generic name
Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog
P73 ST412
Primary DI / UDI-DI
00810021867403
510(k) Number
FDA product code
HWC
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization
MRI safety
MR Conditional
Size
Width — 3.5 Millimeter
Length — 12 Millimeter

Related devices

Category: Orthopaedic bone screw (non-sliding)

Cleared under the same submission (K181113)

and 8 more cleared under K181113

Similar devices in this category

Other devices filed under Orthopaedic bone screw (non-sliding).

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (8, all answered No)