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Paradigm 1200002

by Proprio

Paradigm 1200002 is a Class II device made by Proprio, cleared under FDA 510(k) K222291 on 21 Apr 2023 and listed in FDA GUDID since 5 May 2023 (UDI-DI 00850042604045), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K222291

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 Number00850042604045 UDI-DI Date5 May 2023ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK222291 Date21 Apr 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K222291 decided 21 Apr 2023 Active
  • FDA GUDID UDI-DI 00850042604045 listed 5 May 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K222291
  2. Listed FDA GUDID 00850042604045

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Paradigm
Generic name
Bone holding forceps
Model / Ref / Catalog
1200002
Primary DI / UDI-DI
00850042604045
510(k) Number
FDA product code
OLO
GMDN term
Bone holding forceps
Device class
Class II
Regulation number
882.4560
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K222291)

and 2 more cleared under K222291

Similar devices

Other devices filed under FDA product code OLO (Orthopedic Stereotaxic Instrument).

Other devices from Proprio

See all devices from Proprio →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)