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Quantum M05 01151

by IN2BONES

Quantum M05 01151 is a Class I device made by IN2BONES, cleared under FDA 510(k) K191380 on 29 Jan 2020 and listed in FDA GUDID since 13 Dec 2024 (UDI-DI 03701337601270), 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) K191380

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 Number03701337601270 UDI-DI Date13 Dec 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK191380 Date29 Jan 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191380 decided 29 Jan 2020 Active
  • FDA GUDID UDI-DI 03701337601270 listed 13 Dec 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K191380
  2. Listed FDA GUDID 03701337601270

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Quantum
Generic name
Osteotomy guide, reusable
Model / Ref / Catalog
M05 01151
Primary DI / UDI-DI
03701337601270
510(k) Number
FDA product code
FZX
GMDN term
Osteotomy guide, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Osteotomy guide, reusable

Cleared under the same submission (K191380)

and 8 more cleared under K191380

Other devices from IN2BONES

See all devices from IN2BONES →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)