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Spinal Concepts, Inc.

United StatesFDA applicant, unverified

Devices
33
FDA recalls
8

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Spinal Concepts, Inc. makes

Spinal Concepts, Inc. makes spinal fixation systems, including pedicle screw systems, anterior cervical plate systems, spinal plates, bone plates, cement restrictors, transverse connectors, and related spinal implants and instrumentation.

The company's devices are classified as Class II and are listed in the FDA 510(k) registry; the company is based in the United States.

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

Catalogue33

Newest first, rows 1-33 of 33

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Rows 1-33 of 33

FDA recalls8

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

FDA recall records list 8 recalls initiated by Spinal Concepts, Inc., the earliest on 2002-04-01 and the most recent on 2004-04-01. By recorded status: 8 terminated. The reasons filed fall into these groups: mechanical integrity. 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.

  • 2004

    • 1 Apr 2004 Z-1343-04 Unclassified (pre-2012) Terminated Handle becomes loose after repeated use. Distribution: Product was distributed domestically in the following states: TN, MI, KY, CA, CO, OH, KS, WA, TX, NY, AZ, PA, MA, UT,…
      Full distribution text Product was distributed domestically in the following states: TN, MI, KY, CA, CO, OH, KS, WA, TX, NY, AZ, PA, MA, UT, MO, IN, NV, OR, SD, IL, NJ, WI, OK, FL, GA, VA, NC, MD
      Submission number: K033517
    • 8 Mar 2004 Z-1038-04 Unclassified (pre-2012) Terminated Recall of product literature that describes use of the device. Distribution: Tennessee, Michigan, Washington, Kentucky, California, Colorado, Ohio, Oregon, Kansas, Texas, New York, Virginia,…
      Full distribution text Tennessee, Michigan, Washington, Kentucky, California, Colorado, Ohio, Oregon, Kansas, Texas, New York, Virginia, Florida, Virginia, New Mexico, Minnesota, Louisiana, Wisconsin, Oklahoma, Pennsylvania, North Carolina, Maryland, Arizona, Utah, Missouri, South Dakota, Illinois, and New Jersey
      Submission number: K024326
    • 1 Mar 2004 Z-0807-04 Unclassified (pre-2012) Terminated Design has insufficient articulating distance between the two component plates to prevent disassociation in vivo. Distribution: Nationwide Submission number: K024326
    • 1 Mar 2004 Z-0808-04 Unclassified (pre-2012) Terminated Design has insufficient articulating distance between the two component plates to prevent disassociation in vivo. Distribution: Nationwide Submission number: K024326

  • 2002

    • 1 Jul 2002 Z-0880-05 Unclassified (pre-2012) Terminated Complaints were recieved where swivels came out of plate and where the screw went through the plate. Distribution: Systems were distributed to hospitals in CA, IL, IN, NC, MS, PA, NY and VA Submission number: K013979
    • 1 Apr 2002 Z-0920-04 Unclassified (pre-2012) Terminated The instrument can break during surgery causing delay of surgery and/or fragments in the surgical site. Distribution: Product was distributed to consignees in KY, CA, CO, OH, IN, WA, KS, TX, NY, AZ, NJ, MI, PA, OK, MA, UT, MO, PA, OR, SD,…
      Full distribution text Product was distributed to consignees in KY, CA, CO, OH, IN, WA, KS, TX, NY, AZ, NJ, MI, PA, OK, MA, UT, MO, PA, OR, SD, MN, IL, WI, FL, NC, AL, MD, VA, NM, LA. Product was also distributed to the following foreign countries: Germany, Japan, and Italy
      Submission number: K964404
    • 1 Apr 2002 Z-0921-04 Unclassified (pre-2012) Terminated The instrument can break during surgery causing delay of surgery and/or fragments in the surgical site. Distribution: Product was distributed to consignees in KY, CA, CO, OH, IN, WA, KS, TX, NY, AZ, NJ, MI, PA, OK, MA, UT, MO, PA, OR, SD,…
      Full distribution text Product was distributed to consignees in KY, CA, CO, OH, IN, WA, KS, TX, NY, AZ, NJ, MI, PA, OK, MA, UT, MO, PA, OR, SD, MN, IL, WI, FL, NC, AL, MD, VA, NM, LA. Product was also distributed to the following foreign countries: Germany, Japan, and Italy
      Submission number: K983260
    • 1 Apr 2002 Z-0922-04 Unclassified (pre-2012) Terminated The instrument can break during surgery causing delay of surgery and/or fragments in the surgical site. Distribution: Product was distributed to consignees in KY, CA, CO, OH, IN, WA, KS, TX, NY, AZ, NJ, MI, PA, OK, MA, UT, MO, PA, OR, SD,…
      Full distribution text Product was distributed to consignees in KY, CA, CO, OH, IN, WA, KS, TX, NY, AZ, NJ, MI, PA, OK, MA, UT, MO, PA, OR, SD, MN, IL, WI, FL, NC, AL, MD, VA, NM, LA. Product was also distributed to the following foreign countries: Germany, Japan, and Italy
      Submission number: K983258

Frequently asked questions

How many devices does Spinal Concepts, Inc. have in the registry?

The registry currently lists 33 devices for Spinal Concepts, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Spinal Concepts, Inc.'s devices?

Among its 33 most recently registered devices, Spinal Concepts, Inc. has devices listed in FDA 510(k) (33 devices).

What risk classes do Spinal Concepts, Inc.'s devices fall under?

Among its 33 most recently registered devices, the classes recorded for Spinal Concepts, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Spinal Concepts, Inc.?

FDA recall records list 8 recalls initiated by Spinal Concepts, Inc., the most recent initiated on 1 Apr 2004. 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 Spinal Concepts, Inc. in the registry?

The most recently registered devices listed for Spinal Concepts, Inc. include SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM, UNIVERSAL BONE PLATE III SYSTEM (UBP III), MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM and SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II.

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