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BIO2 Technologies 100-0259

by BIO2 Technologies, Inc.

BIO2 Technologies 100-0259 is a Class II device made by BIO2 Technologies, Inc., cleared under FDA 510(k) K142463 on 18 Dec 2014 and listed in FDA GUDID since 1 Nov 2017 (UDI-DI B0101000259), 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) K142463

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 NumberB0101000259 UDI-DI Date1 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK142463 Date18 Dec 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K142463 decided 18 Dec 2014 Active
  • FDA GUDID UDI-DI B0101000259 listed 1 Nov 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K142463
  2. Listed FDA GUDID B0101000259

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
BIO2 Technologies
Generic name
Synthetic bone graft
Model / reference
100-0259
Primary DI / UDI-DI
B0101000259
510(k) Number
FDA product code
MQV
GMDN term
Synthetic bone graft
Device class
Class II
Regulation number
888.3045
GUDID distribution status
In Commercial Distribution

Related devices

Category: Synthetic bone graft

Cleared under the same submission (K142463)

and 8 more cleared under K142463

Similar devices in this category

Other devices filed under Synthetic bone graft.

Other devices from BIO2 Technologies, Inc.

See all devices from BIO2 Technologies, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (8, all answered No)