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Prima 1367.09.406

by Limacorporate

Prima 1367.09.406 is a Class II device made by Limacorporate, cleared under FDA 510(k) K252352 on 22 Jan 2026 and listed in FDA GUDID since 19 Feb 2026 (UDI-DI 08033390202497), 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) K252352

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 Number08033390202497 UDI-DI Date19 Feb 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK252352 Date22 Jan 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K252352 decided 22 Jan 2026 Active
  • FDA GUDID UDI-DI 08033390202497 listed 19 Feb 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K252352
  2. Listed FDA GUDID 08033390202497

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Prima
Generic name
Metallic reverse shoulder prosthesis cup
Model / Ref / Catalog
1367.09.406
Primary DI / UDI-DI
08033390202497
510(k) Number
FDA product code
PHX, MBF
GMDN term
Metallic reverse shoulder prosthesis cup
Device class
Class II
Regulation number
888.3660, 888.3670
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K252352)

and 8 more cleared under K252352

Similar devices

Other devices filed under FDA product code PHX (Shoulder Prosthesis, Reverse Configuration).

Other devices from Limacorporate

See all devices from Limacorporate →

Properties

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