Modification to Endius Atavi System
FDA 510(k) K061345 · Endius, Inc.
510(k) numberK061345
Submission
- Device name
- Modification to Endius Atavi System
- Applicant
- Endius, Inc.
Plainville, MA, US - Received
- May 15, 2006
- Decision date
- June 6, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRX – Arthroscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.1100
- Specialty
- Orthopedic
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code HRX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260203 | Fule Vertebroplasty Balloon CatheterHRX · Traditional | Beijing Fule Science & Technology Development… | 08/28/2026SE |
| K254103 | HOPKINS Telescopes for ArthroscopyHRX · Traditional | Karl Storz SE & CO. KG | 08/26/2026SE |
| K252790 | Digital ClarusScope System and Digital NeuroPEN SystemHRX · Traditional | Clarus Medical, LLC | 05/26/2026SE |
| K253523 | Freedom DS Decompression SystemHRX · Traditional | Spinal Simplicity | 04/16/2026SE |
| K252546 | VantageTM Lumbar Decompression KitHRX · Traditional | Allevion Medical, LLC | 03/12/2026SE |
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500)…HRX · Traditional | Medimaging Integrated Solution, Inc (Miis) | 12/23/2025SE |
| K250795 | Purevue FMSHRX · Traditional | W.O.M. World of Medicine GmbH | 12/05/2025SE |
| K252666 | Articulator Arthroscopic BurHRX · Traditional | Joint Preservation Innovations, LLC | 11/21/2025SE |
| K252458 | Kyphoplasty Balloon Dilatation CathetersHRX · Traditional | Shanghai Lange Medtech Co., Ltd. | 11/03/2025SE |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHRX · Traditional | Hand Biomechanics Lab, Inc. | 10/15/2025SE |
More from Hand Biomechanics Lab, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K080258 | Modification to Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemNKB · Traditional | 03/10/2008SE |
| K073510 | Endius Title 2 Poly Axial Spinal SystemNKB · Traditional | 02/11/2008SE |
| K073267 | Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemNKB · Traditional | 01/30/2008SE |
| K072840 | Endius Title 2 Polyaxial Spinal SystemNKB · Traditional | 12/07/2007SE |
| K070282 | Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemNKB · Traditional | 09/06/2007SE |
| K070367 | Endius Title 2 Polyaxial Spinal SystemNKB · Traditional | 04/12/2007SE |
| K060990 | Endius Title 2 Poly Axial Spinal SystemNKB · Traditional | 04/26/2006SE |
| K060683 | Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemKWP · Traditional | 04/18/2006SE |
| K053267 | Endius Atavi SystemHRX · Traditional | 01/13/2006SE |
| K041808 | Endius Title 2 Polyaxial Spinal SystemKWP · Special | 10/01/2004SE |
Questions and answers
When was Modification to Endius Atavi System cleared by the FDA?
Modification to Endius Atavi System (K061345) received a 510(k) decision of Substantially Equivalent on June 6, 2006, 22 days after the submission was received.
What is the product code of K061345?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.