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FDA 510(k)

EBI XFIX DFS RAIL SYSTEM

K-Number: K991941 · 1999-08-19

ApplicantElectro-Biology, Inc.
Decision Date1999-08-19
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EBI XFIX DFS RAIL SYSTEM 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 1999-08-19 under 510(k) number K991941. 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 XFIX DFS RAIL SYSTEM?

EBI XFIX DFS RAIL SYSTEM is a medical device that received FDA 510(k) clearance on 1999-08-19. The listed applicant is Electro-Biology, Inc.. The 510(k) number is K991941.

When did EBI XFIX DFS RAIL SYSTEM receive FDA 510(k) clearance?

EBI XFIX DFS RAIL SYSTEM received FDA 510(k) clearance on 1999-08-19, under 510(k) number K991941.

Who is the listed applicant for EBI XFIX DFS RAIL SYSTEM?

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 XFIX DFS RAIL SYSTEM?

The FDA product code for EBI XFIX DFS RAIL SYSTEM 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 SCREWSK991092EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEMK990303EBI OMEGA 21 SYSTEMK990459EBI VUECATH ENDOSCOPIC SYSTENK990999MODIFICATION OF: EBI SPINELINK SYSTEM

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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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