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FDA 510(k)

HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX

K-Number: K102885 · 2011-01-14

ApplicantStryker Corp.
Decision Date2011-01-14
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 2011-01-14 under 510(k) number K102885. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX?

HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX is a medical device that received FDA 510(k) clearance on 2011-01-14. The listed applicant is Stryker Corp.. The 510(k) number is K102885.

When did HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX receive FDA 510(k) clearance?

HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX received FDA 510(k) clearance on 2011-01-14, under 510(k) number K102885.

Who is the listed applicant for HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX?

The FDA 510(k) record lists Stryker Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX?

The FDA product code for HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX is JEC.

Related Clinical Trials

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Other records listing Stryker Corp. as applicant

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Related Devices (Code: JEC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203605SteriTrakArbutus Medical, Inc.K193256Anjon Bremer Halo SystemAnjon Holdings, LLCK192465DigiFix Sterile KitVirak Orthopedics, LLCK181192PIP FixHand Biomechanics Lab, Inc.K171863Anjon Bremer Halo SystemAnjon Holdings, LLCK163028Medline ReNewal Reprocessed Stryker External Fixation DevicesSurgical Instrument Service and Savings, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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