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FDA 510(k)

MODIFICATION TO EBI SPINELINK SYSTEM

K-Number: K982908 · 1998-08-28

ApplicantElectro-Biology, Inc.
Decision Date1998-08-28
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO EBI SPINELINK 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 1998-08-28 under 510(k) number K982908. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO EBI SPINELINK SYSTEM?

MODIFICATION TO EBI SPINELINK SYSTEM is a medical device that received FDA 510(k) clearance on 1998-08-28. The listed applicant is Electro-Biology, Inc.. The 510(k) number is K982908.

When did MODIFICATION TO EBI SPINELINK SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO EBI SPINELINK SYSTEM received FDA 510(k) clearance on 1998-08-28, under 510(k) number K982908.

Who is the listed applicant for MODIFICATION TO EBI SPINELINK 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 MODIFICATION TO EBI SPINELINK SYSTEM?

The FDA product code for MODIFICATION TO EBI SPINELINK SYSTEM is KWP.

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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: KWP)

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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, 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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