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Atlas 11200

by Parcus Medical LLC

Atlas 11200 is a Class II device made by Parcus Medical LLC, cleared under FDA 510(k) K190375 on 24 Apr 2019 and listed in FDA GUDID since 7 Oct 2019 (UDI-DI M685112000), active as of 23 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 23 Oct 2026

Documents

510(k) K190375

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM685112000 UDI-DI Date7 Oct 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK190375 Date24 Apr 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K190375 decided 24 Apr 2019 Active
  • FDA GUDID UDI-DI M685112000 listed 7 Oct 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K190375
  2. Listed FDA GUDID M685112000

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Atlas
Generic name
Metacarpal prosthesis
Model / Ref / Catalog
11200
Primary DI / UDI-DI
M685112000
510(k) Number
FDA product code
MBI
GMDN term
Metacarpal prosthesis
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Metacarpal prosthesis

Similar devices

Other devices filed under FDA product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Other devices from Parcus Medical LLC

See all devices from Parcus Medical LLC →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)