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Techfit 0

by Techfit Digital Surgery, Inc. 45 variants

Techfit 0 (MAPMANI2P), a custom-made organ/bone anatomy model (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Techfit Digital Surgery, Inc., was cleared under FDA 510(k) K222577 on 6 Jan 2023 and listed in FDA GUDID on 18 Dec 2023 (UDI-DI 00860010801697); the registry lists it as 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) K222577

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 Number00860010801697 UDI-DI Date18 Dec 2023ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK222577 Date6 Jan 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K222577 decided 6 Jan 2023 Active
  • FDA GUDID UDI-DI 00860010801697 listed 18 Dec 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K222577
  2. Listed FDA GUDID 00860010801697

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Techfit
Generic name
Custom-made organ/bone anatomy model
Model / Ref / Catalog
0, MAPMANI2P
Primary DI / UDI-DI
00860010801697
510(k) Number
FDA product code
LLZ
GMDN term
Custom-made organ/bone anatomy model
Device class
Class II
Regulation number
892.2050
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Custom-made organ/bone anatomy model

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from Techfit Digital Surgery, Inc.

See all devices from Techfit Digital Surgery, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (10, all answered No)