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FDA 510(k)

OMI OCCIPITAL CERVICAL LOOP, MODEL A1089

K-Number: K983282 · 1998-11-19

ApplicantOhio Medical Instrument Co., Inc.
Decision Date1998-11-19
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 is the device name listed in this FDA 510(k) record. The listed applicant is Ohio Medical Instrument Co., Inc.. It received FDA 510(k) clearance on 1998-11-19 under 510(k) number K983282. 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 OMI OCCIPITAL CERVICAL LOOP, MODEL A1089?

OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 is a medical device that received FDA 510(k) clearance on 1998-11-19. The listed applicant is Ohio Medical Instrument Co., Inc.. The 510(k) number is K983282.

When did OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 receive FDA 510(k) clearance?

OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 received FDA 510(k) clearance on 1998-11-19, under 510(k) number K983282.

Who is the listed applicant for OMI OCCIPITAL CERVICAL LOOP, MODEL A1089?

The FDA 510(k) record lists Ohio Medical Instrument Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMI OCCIPITAL CERVICAL LOOP, MODEL A1089?

The FDA product code for OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 is KWP.

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Other records listing Ohio Medical Instrument Co., 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.

K021604MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020K013428MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEMK992843THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT FK991267SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING AK982244MAYFIELD ACCISS OPTICAL SYSTEMK960807TEW CRANIAL/SPINAL RETRACTOR MODEL A1090

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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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