Skip to content

Theken Spine, LLC

United StatesFDA applicant, unverified

Devices
23
FDA recalls
6

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Theken Spine, LLC makes

Theken Spine, LLC manufactures spinal fixation and fusion systems, including pedicle screw assemblies, anterior cervical plates, vertebral body replacement devices, and intervertebral body fusion implants. Their portfolio includes modular cervical-thoracic and oct spinal systems, thoracic fixation solutions, and mesh-based vertebral body replacement systems. Products are designed for surgical stabilization and reconstruction of the spine, covering cervical, thoracic, and lumbar regions.

All listed devices fall under Class II regulatory classification in the US and are authorised via 510(k) clearance through the FDA. The company’s products are registered under the FDA’s 510(k) pathway, ensuring compliance with US medical device regulations. No additional registries or international listings are referenced in the provided data.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue23

Newest first, rows 1-23 of 23

Search and filter all 23 devices
Skip device list

Rows 1-23 of 23

FDA recalls6

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 6 recalls initiated by Theken Spine, LLC, the earliest on 2005-10-04 and the most recent on 2010-08-26. By recorded status: 6 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2010

    • 26 Aug 2010 Z-0169-2011 Unclassified (pre-2012) Terminated The firm's quality control testing determined that a separation was occurring between the flowable carrier and the B-TriCalcium Phosphate within some of the product syringes. Distribution: Nationwide Distribution - including UT, SD, TX, AL, PA, CA, MI, OH, NJ, NH, MD, ID, FL, LA, NM, TN, IA, and OR. Submission number: K053228
    • 29 Jul 2010 Z-0087-2011 Unclassified (pre-2012) Terminated The Manta Ray Cervical System was subject to corrective action by the firm after two (2) customer complaints were received alleging that screws were 'backing out' of the device during surgical procedures. Distribution: Nationwide Distribution - USA including AL, AZ, CA, CT, FL, GA, HI, IL, ID, IN, KS, LA, MI, MD, MN, MA, MD, MS, NE, NY,…
      Full distribution text Nationwide Distribution - USA including AL, AZ, CA, CT, FL, GA, HI, IL, ID, IN, KS, LA, MI, MD, MN, MA, MD, MS, NE, NY, NC, NJ, NV, NM, OH, OR, OK, PA, TN, TX, UT, WI, and WA.WA.
      Submission number: K080690

  • 2008

    • 27 Aug 2008 Z-0272-2009 Unclassified (pre-2012) Terminated The kits were manufactured in 2005 with syringes that expire on 10/2009 and labeled with an overall expiration on 10/2010. Distribution: Nationwide Distribution --- including states of CA, NC, NJ, NM, NY, TX, and UT. Submission number: K993435
    • 26 Aug 2008 Z-1965-2009 Unclassified (pre-2012) Terminated Failure to label the product properly. Additionally, 15 pieces were reworked and the expiration date was misprinted as 2011-04 instead of the actual date of 2010-04. Distribution: Nationwide Distribution -- TX. Submission number: K040134
    • 11 Jul 2008 Z-2375-2008 Unclassified (pre-2012) Terminated The patient label inside the package has an expiration date of 2008-06 when the actual expiration date is 2010-06. Distribution: Nationwide Distribution --- including states of FL, OH, TX, and UT. Submission number: K053228

  • 2005

    • 4 Oct 2005 Z-0183-06 Unclassified (pre-2012) Terminated The torque value of the device may increase over time. The increase could exceed the tolerance specification. Distribution: The product was distributed to AL, AR, CA, FL, ID, IN, KS, LA, MO, NJ, OH, PA, TX, UT, WA, WV. Submission number: K041592

Frequently asked questions

How many devices does Theken Spine, LLC have in the registry?

The registry currently lists 23 devices for Theken Spine, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list Theken Spine, LLC's devices?

Among its 23 most recently registered devices, Theken Spine, LLC has devices listed in FDA 510(k) (23 devices).

What risk classes do Theken Spine, LLC's devices fall under?

Among its 23 most recently registered devices, the classes recorded for Theken Spine, LLC's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Theken Spine, LLC?

FDA recall records list 6 recalls initiated by Theken Spine, LLC, the most recent initiated on 26 Aug 2010. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Theken Spine, LLC in the registry?

The most recently registered devices listed for Theken Spine, LLC include THEKEN ATOLL CERVICO-THORACIC SYSTEM, THEKEN ATOLL OCT SPINAL SYSTEM, CORAL PEDICLE SCREW SYSTEM and MODIFICATION TO CORAL SPINAL SYSTEM.

Generated automatically from registry data and not verified by a human reviewer.