PMT Halo System
FDA 510(k) K090733 · Pmt Corp.
510(k) numberK090733
Submission
- Device name
- PMT Halo System
- Applicant
- Pmt Corp.
Chanhassen, MN, US - Received
- March 19, 2009
- Decision date
- July 28, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HAX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K071173 | Resolve Tongs, Small/Medium, Resolve Tongs, Medium/Large, Model JT-200D, JT-100DHAX · Special | Ossur Americans (Formerly the Jerome Group) | 05/25/2007SE |
| K051918 | Resolve Open Back Halo RingsHAX · Special | Jerome Medical | 08/17/2005SE |
| K023959 | Jerome Glass RingHAX · Traditional | The Jerome Group, Inc. | 02/21/2003SE |
| K003662 | Spine Works CollarHAX · Traditional | Spine Works | 07/09/2001SE |
| K980689 | Friddle Halo System, Friddle MRI Halo SystemHAX · Traditional | Friddle'S Orthopedic Appliances, Inc. | 02/18/1999SE |
| K930021 | J TongsHAX · Traditional | Jerome Medical | 12/06/1995SE |
| K954069 | Ace Cervical Traction Halozs, Tongs & PinsHAX · Traditional | Ace Medical Co. | 10/12/1995SE |
| K924606 | Bremer Imaging Tongs-Mri ModelHAX · Traditional | Bremer Medical, Inc. | 09/09/1993SE |
| K915530 | Nova Gauze(R) Disposable Nonwoven Sponges, SterileHAX · Traditional | American Threshold Industries, Inc. | 08/17/1992SE |
| K873693 | Levtech Composite Traction TongsHAX · Traditional | Levtech, Inc. | 02/05/1988SE |
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| K042901 | Endomark Sterile India InkNBG · Traditional | 03/16/2005SE |
| K033730 | PMT Sphenoidal Electrode and Accessory, Model 2101-31 and 2102-31 SeriesGZL · Traditional | 08/03/2004SE |
| K972597 | PMT New Beginnings Gelshapes & AmendMDA · Traditional | 10/01/1997SE |
| K970418 | PMT Accessory Depthalon Electrode Anchor Bolt (2103-23-XX)GZL · Traditional | 04/29/1997SE |
| K964224 | Stainless Steel Cortac Cortical ELECTRODE(2111)/PLANTINUM Cortac Cortical ElectrodeGYC · Traditional | 03/19/1997SE |
| K935560 | PMT External External Drainage System (Eds)JXG · Traditional | 11/07/1994SE |
Questions and answers
When was PMT Halo System cleared by the FDA?
PMT Halo System (K090733) received a 510(k) decision of Substantially Equivalent on July 28, 2009, 131 days after the submission was received.
What is the product code of K090733?
The FDA product code is HAX – Tong, Skull For Traction, a Class II (moderate risk) device regulated under 21 CFR 882.5960.