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FDA 510(k)

EBI X FIX DYNAFIX SYSTEM (DFS)

K-Number: K953406 · 1995-10-31

ApplicantElectro-Biology, Inc.
Decision Date1995-10-31
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EBI X FIX DYNAFIX SYSTEM (DFS) is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Biology, Inc.. It received FDA 510(k) clearance on 1995-10-31 under 510(k) number K953406. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBI X FIX DYNAFIX SYSTEM (DFS)?

EBI X FIX DYNAFIX SYSTEM (DFS) is a medical device that received FDA 510(k) clearance on 1995-10-31. The listed applicant is Electro-Biology, Inc.. The 510(k) number is K953406.

When did EBI X FIX DYNAFIX SYSTEM (DFS) receive FDA 510(k) clearance?

EBI X FIX DYNAFIX SYSTEM (DFS) received FDA 510(k) clearance on 1995-10-31, under 510(k) number K953406.

Who is the listed applicant for EBI X FIX DYNAFIX SYSTEM (DFS)?

The FDA 510(k) record lists Electro-Biology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EBI X FIX DYNAFIX SYSTEM (DFS)?

The FDA product code for EBI X FIX DYNAFIX SYSTEM (DFS) is KTT.

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Other records listing Electro-Biology, Inc. as applicant

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.

K992333EBI OMEGA 21 SYSTEMK992367EBI XFIX DYNAFIX SYSTEM HA COATED SCREWSK991941EBI XFIX DFS RAIL SYSTEMK990303EBI OMEGA 21 SYSTEMK991092EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEMK990459EBI VUECATH ENDOSCOPIC SYSTEN

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Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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