Powerease System
FDA 510(k) K123270 · Medtronic Sofamor Danek USA, Inc.
510(k) numberK123270
Submission
- Device name
- Powerease System
- Applicant
- Medtronic Sofamor Danek USA, Inc.
Memphis, TN, US - Received
- October 19, 2012
- Decision date
- January 11, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HBE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253627 | Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo…HBE · Traditional | Surgify Medical OY | 03/26/2026SE |
| K250815 | Hubly Drill (H100)HBE · Traditional | Hubly, Inc. | 11/06/2025SE |
| K252060 | GreenHBE · Traditional | Phasor Health, LLC | 10/31/2025SE |
| K252662 | UniBurHBE · Traditional | Nakanishi, Inc. | 09/19/2025SE |
| K251433 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…HBE · Special | Surgify Medical OY | 06/04/2025SE |
| K250380 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…HBE · Special | Surgify Medical OY | 03/13/2025SE |
| K250374 | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round…HBE · Special | Stryker Instruments | 03/11/2025SE |
| K232684 | Surgify HaloHBE · Traditional | Surgify Medical OY | 11/29/2023SE |
| K230619 | Hubly Electric Drill (H100)HBE · Traditional | Hubly, Inc. | 05/04/2023SE |
| K223199 | 2.1 x 255mm Drill, 22mm StopHBE · Special | Biomet Microfixation | 11/15/2022SE |
More from Biomet Microfixation
| 510(k) | Device | Decision |
|---|---|---|
| K253011 | Catalyft PL Expandable Interbody SystemMAX · Traditional | 07/17/2026SE |
| K261020 | Symmetrix L Spinal SystemMAX · Traditional | 07/14/2026SE |
| K253656 | OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation SystemGEI · Traditional | 06/05/2026SE |
| K260216 | CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal SystemNKB · Traditional | 04/21/2026SE |
| K254165 | Infinity OCT SystemNKG · Special | 01/21/2026SE |
| K253941 | CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly)NKB · Special | 01/07/2026SE |
| K253335 | CD Horizon Spinal SystemNKB · Special | 10/24/2025SE |
| K253129 | Infinity OCT SystemNKG · Special | 10/24/2025SE |
| K251444 | Endoskeleton Interbody SystemsMAX · Traditional | 09/04/2025SE |
| K251395 | The Rialto SI Fusion SystemOUR · Traditional | 06/26/2025SE |
Questions and answers
When was Powerease System cleared by the FDA?
Powerease System (K123270) received a 510(k) decision of Substantially Equivalent on January 11, 2013, 84 days after the submission was received.
What is the product code of K123270?
The FDA product code is HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4310.