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Immedica, Inc.

United StatesFDA applicant, unverified

Devices
8
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Immedica, Inc. makes

Immedica, Inc. makes external fixation systems and related components for orthopedic trauma and reconstructive surgery, including the TRANSFX External Fixation System and its variants such as the TRANSFX Adjustable Pin to Bar Clamp, TRANSFX Multi Pin Clamp, TRANSFX Angled Rods, and External Fixation Anchor Pin. The company also produces radiopaque bone cement products, including CONCERT Radiopaque Bone Cement and CONCERT Cranioplast, used for bone void filling and cranial reconstruction.

These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry. Immedica, Inc. is based in the United States.

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

Catalogue8

Newest first, rows 1-8 of 8

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Immedica, Inc., initiated on 2003-02-10. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use. 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.

  • 2003

    • 10 Feb 2003 Z-0907-03 Unclassified (pre-2012) Terminated Mislabeled; wrong identification number on pin. Distribution: The product is only distributed to Zimmers Patient Care Division, P.O. Box 569, Dover, OH 44622. There are no government…
      Full distribution text The product is only distributed to Zimmers Patient Care Division, P.O. Box 569, Dover, OH 44622. There are no government accounts.
      Submission number: K990848

Frequently asked questions

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

The registry currently lists 8 devices for Immedica, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Immedica, Inc.'s devices?

Among its 8 most recently registered devices, Immedica, Inc. has devices listed in FDA 510(k) (8 devices).

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

Among its 8 most recently registered devices, the classes recorded for Immedica, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Immedica, Inc.?

FDA recall records list 1 recall initiated by Immedica, Inc., the most recent initiated on 10 Feb 2003. 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 Immedica, Inc. in the registry?

The most recently registered devices listed for Immedica, Inc. include TRANSFX EXTERNAL FIXATION SYSTEM, TRANS FX ADJUSTABLE PIN TO BAR CLAMP, CONCERT RADIOPAQUE BONE CEMENT and TRANSFX MULTI PIN CLAMP.

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