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Bio2 Technologies 1000036

by BIO2 Technologies, Inc.

Bio2 Technologies 1000036 is a Class II device made by BIO2 Technologies, Inc., cleared under FDA 510(k) K152589 on 12 Jan 2016 (1 earlier submission) and listed in FDA GUDID since 1 Jun 2016 (UDI-DI B01010000361), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB01010000361 UDI-DI Date1 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK152589 Date12 Jan 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K152589 decided 12 Jan 2016 Active· +1 more in the status table
  • FDA GUDID UDI-DI B01010000361 listed 1 Jun 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K142463
  2. Cleared FDA 510(k) K152589
  3. Listed FDA GUDID B01010000361

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  • Withdrawn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
1000036
Description
VITRIUM E 18 x 6
Primary DI / UDI-DI
B01010000361
510(k) Number
FDA product code
OIS, 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

Cleared under the same submission (K152589)

and 8 more cleared under K152589

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
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)