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FDA 510(k)

THE OSTEOMED B POWER SYSTEM AND ACCESSORIES

K-Number: K933101 · 1994-11-07

ApplicantOsteomed Corp.
Decision Date1994-11-07
Product CodeKIJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THE OSTEOMED B POWER 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 1994-11-07 under 510(k) number K933101. The device is classified under product code KIJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE OSTEOMED B POWER SYSTEM AND ACCESSORIES?

THE OSTEOMED B POWER SYSTEM AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1994-11-07. The listed applicant is Osteomed Corp.. The 510(k) number is K933101.

When did THE OSTEOMED B POWER SYSTEM AND ACCESSORIES receive FDA 510(k) clearance?

THE OSTEOMED B POWER SYSTEM AND ACCESSORIES received FDA 510(k) clearance on 1994-11-07, under 510(k) number K933101.

Who is the listed applicant for THE OSTEOMED B POWER 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 THE OSTEOMED B POWER SYSTEM AND ACCESSORIES?

The FDA product code for THE OSTEOMED B POWER SYSTEM AND ACCESSORIES is KIJ.

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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: KIJ)

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.

K163308SMARTOJeil Medical CorporationK112599INSURGICAL SINGLE USE POWER EQUIPMENTInsurgical, LLCK101563SMARTOJeil Medical CorporationK972367STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENTStryker InstrumentsK970378STRYKER 2115 REPLACEMENT BATTERY (2115)Implant Resource, Inc.K960711ACUMED BONE GRAFT SYSTEMAcu Med, 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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