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FDA 510(k)

J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE

K-Number: K935113 · 1994-10-19

ApplicantJ.B.S., S.A.
Decision Date1994-10-19
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is J.B.S., S.A.. It received FDA 510(k) clearance on 1994-10-19 under 510(k) number K935113. 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 J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE?

J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE is a medical device that received FDA 510(k) clearance on 1994-10-19. The listed applicant is J.B.S., S.A.. The 510(k) number is K935113.

When did J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE receive FDA 510(k) clearance?

J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE received FDA 510(k) clearance on 1994-10-19, under 510(k) number K935113.

Who is the listed applicant for J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE?

The FDA 510(k) record lists J.B.S., S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE?

The FDA product code for J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE is KWP.

Related Clinical Trials

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.

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Other records listing J.B.S., S.A. 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.

K962757J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMPK955864J.B. S. C1-C2 CLAMPK953881SPINE SYSTEM SACRAL PLATEK953599CLAMP ASSEMBLYK952298SPINAL PEDICLE SCREW, FIXATION, APPLIANCEK942432J.B.S. CERVICAL SPINE SYSTEM

View all 10 devices →

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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