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FDA 510(k)

SLEEP-IN BONE SCREW SYSTEM

K-Number: K972023 · 1997-08-25

ApplicantInfluence, Inc.
Decision Date1997-08-25
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SLEEP-IN BONE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Influence, Inc.. It received FDA 510(k) clearance on 1997-08-25 under 510(k) number K972023. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLEEP-IN BONE SCREW SYSTEM?

SLEEP-IN BONE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 1997-08-25. The listed applicant is Influence, Inc.. The 510(k) number is K972023.

When did SLEEP-IN BONE SCREW SYSTEM receive FDA 510(k) clearance?

SLEEP-IN BONE SCREW SYSTEM received FDA 510(k) clearance on 1997-08-25, under 510(k) number K972023.

Who is the listed applicant for SLEEP-IN BONE SCREW SYSTEM?

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

What is the FDA product code for SLEEP-IN BONE SCREW SYSTEM?

The FDA product code for SLEEP-IN BONE SCREW SYSTEM is LRK.

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Other records listing Influence, 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.

K981677REPOSE BONE SCREW SYSTEMK991792CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBEK992277STAPLETAC BONE ANCHOR SYSTEMK991122CRYO-MONO CRYOGRNIC SYSTEMK990160MICROTAC-BONE ANCHOR SYSTEMK990095STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM

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Related Devices (Code: LRK)

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.

K262104Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)Ram.Shaw Pte., Ltd.K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLC

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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