510(k) K051013
- Device
- SPINEMED S200B/S200C
- Applicant
- CERT HEALTH SCIENCES, LLC
- 510(k) number
- K051013
- Product code
- ITH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-04-27
- Date received
- 2005-04-21
- Regulation
- 890.5900
- Classification name
- Equipment, Traction, Powered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- TIM R EMSKY
- Address
- 10440 Little Patuxent Pkwy. Suite 300 Columbia MD US 21044 21044
FDA Registration Numbers#
- 3004755153
- 3002654235
- 3008585473
- 9613446
- 9617486
- 2013558
- 3007278668
- 3006042614
- 3008816697
- 1067107
- 8010720
- 3017264244
- 2510425
- 9614750
- 9616086
- 9616877
- 9612147
Source Documents#
Other 510(k) Records For Product Code ITH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243775 | True Non-Surgical Spinal Decompression System (DRX9000-SL) | Excite Medical of Tampa Bay, LLC | 2025-07-18 |
| K243366 | DRX9000C-SL Cervical Spinal Decompression System | Excite Medical of Tampa Bay, LLC | 2025-06-18 |
| K214037 | Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac | Ergo-Flex Technologies, LLC | 2024-02-22 |
| K222912 | c1Trac | Zimmer Medizinsysteme GmbH | 2023-05-16 |
| K151640 | ELTRAC 471 | Enraf-Nonius, B.V. | 2015-10-16 |
| K150695 | Modpod | Hollywog, LLC | 2015-08-13 |
| K131983 | ITRAC CERVICAL TRACTION SYSTEM | Pivotal Health Solutions | 2014-09-10 |
| K130249 | INTEGRITY SPINAL CARE SYSTEM 3.0 | Integrity Life Sciences | 2014-02-06 |
| K112074 | EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 | Everyway Medical Instruments Co.,Ltd | 2012-02-01 |
| K103248 | INTEGRITY SPINAL CARE SYSTEM | Integra Life Sciences | 2011-04-05 |
| K101889 | DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE | Pivotal Health Solutions | 2010-08-27 |
| K091540 | MTD 4000 | Mettler Electronics Corp. | 2009-10-08 |
| K081247 | TM-400 | Ito Co., Ltd. | 2008-08-25 |
| K072064 | GRAVILAX TRACTION SYSTEM | Therapeutic Clinical Technologies, Inc. | 2008-04-21 |
| K073132 | MODEL D DISC FORCE | North American Medical Corp (Nam) | 2008-04-03 |
Legacy Summary#
summary
FDA Review#
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