Bone Screw

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K893203 ↗

FDA Product Code

JDR

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Crank Frame Retractor

  Class II

  FDA 510(k) K882071 Active Cleared 10 Jun 1988

• Suction Retractors

  Class I

  FDA 510(k) K882074 Active Cleared 16 Jun 1988

• Spinal Distractors, Spanners

  Class I

  FDA 510(k) K882069 Active Cleared 17 Jun 1988

• Cobb Spinal Elevators

  Class II

  FDA 510(k) K882068 Active Cleared 3 Jun 1988

• Lumbar Impaction Set and Bone Graft Impactors

  Class II

  FDA 510(k) K882070 Active Cleared 3 Jun 1988

• Self-Retaining Soft Tissue Retractor

  Class I

  FDA 510(k) K882075 Active Cleared 16 Jun 1988

See all devices from Karlin Technology, Inc. →

• What is the BONE SCREW used for?

  The BONE SCREW is an orthopedic device used for fixation in bone, intended for use in orthopedic applications to stabilize bone fragments or attach implants to bone.

• How is the BONE SCREW supplied and is it sterile?

  The device data does not specify supply format, sterility, or single-use/reuse status; these details are not included in the provided authorization or specification fields.

• What regulatory pathway was used for the BONE SCREW clearance?

  The BONE SCREW received FDA 510(k) clearance through the traditional pathway, as indicated by the clearance_type field, with decision_code SESE showing it was found substantially equivalent.

• What are the key identifiers for this BONE SCREW model?

  This device is identified by the name BONE SCREW, manufacturer Karlin Technology, Inc., product code JDR, and FDA 510(k) number K893203, which distinguishes it from other similar devices.