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FDA 510(k)

OSTEOPOWER SYSTEM AND ACCESSORIES

K-Number: K971692 · 1997-06-27

ApplicantOsteomed Corp.
Decision Date1997-06-27
Product CodeKMW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOPOWER SYSTEM AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed Corp.. It received FDA 510(k) clearance on 1997-06-27 under 510(k) number K971692. The device is classified under product code KMW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEOPOWER SYSTEM AND ACCESSORIES?

OSTEOPOWER SYSTEM AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1997-06-27. The listed applicant is Osteomed Corp.. The 510(k) number is K971692.

When did OSTEOPOWER SYSTEM AND ACCESSORIES receive FDA 510(k) clearance?

OSTEOPOWER SYSTEM AND ACCESSORIES received FDA 510(k) clearance on 1997-06-27, under 510(k) number K971692.

Who is the listed applicant for OSTEOPOWER SYSTEM AND ACCESSORIES?

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

What is the FDA product code for OSTEOPOWER SYSTEM AND ACCESSORIES?

The FDA product code for OSTEOPOWER SYSTEM AND ACCESSORIES is KMW.

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Other records listing Osteomed Corp. 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.

K022277OSTEOMED CRANIAL FLAP FIXATION SYSTEMK022887INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMK022886METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMK0232601.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEMK013618INTRAORAL MANDIBULAR DISTRACTION SYSTEMK021618OSA RIGID INTERNAL FIXATION SYSTEM

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Related Devices (Code: KMW)

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.

K211584Oral Surgery ContraNakanishi, Inc.K171155Surgical Angle Handpiece, Surgical Straight HandpieceNakanishi, Inc.K162544OsteoMed PINNACLE DriverOsteomedK080939SURGICAL HANDPIECES, MIKRO SAW HANDPIECESW&H Dentalwerk Buermoos GmbHK994298FRIOS MICROSAWFriadent GmbHK970953E-TYPE SPEED REDUCER CONTRA ANGLENsk Nakanishi, 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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