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Ball Joint Guide Array (66295)

by Bayer Medical Care Inc.

510(k) K250893

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Overview

For the Ball Joint Guide Array (66295), a neurosurgical instrument used in stereotactic surgery, designed to improve precision and accuracy. Developed by Bayer Medical Care, Inc., this device is classified under medical devices and falls under the category of neurological instruments.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK250893 Date4 Sep 2025ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HAW
FDA applicant
Bayer Medical Care, Inc.
Device class
Class II
Regulation
21 CFR Part 882.4560
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K250893

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K250893
UDI-DISize and differences
Ball Joint Guide Array (BJGA)-Guide Set 66294
Bayer Medical Care B.V.
6629408720892330833
Prescription: no
On the market
Ball Joint Guide Array (BJGA)-Navigation Set 66293
Bayer Medical Care B.V.
6629308720892330826
Prescription: yes
On the market

Similar devices

Other devices filed under FDA product code HAW (Neurological Stereotaxic Instrument).

Other devices from Bayer Medical Care Inc.

See all devices from Bayer Medical Care Inc. →