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FDA 510(k)

OSTEOMED SBF SYSTEM (SBF)

K-Number: K911936 · 1991-08-21

ApplicantOsteomed Corp.
Decision Date1991-08-21
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOMED SBF SYSTEM (SBF) is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed Corp.. It received FDA 510(k) clearance on 1991-08-21 under 510(k) number K911936. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEOMED SBF SYSTEM (SBF)?

OSTEOMED SBF SYSTEM (SBF) is a medical device that received FDA 510(k) clearance on 1991-08-21. The listed applicant is Osteomed Corp.. The 510(k) number is K911936.

When did OSTEOMED SBF SYSTEM (SBF) receive FDA 510(k) clearance?

OSTEOMED SBF SYSTEM (SBF) received FDA 510(k) clearance on 1991-08-21, under 510(k) number K911936.

Who is the listed applicant for OSTEOMED SBF SYSTEM (SBF)?

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 OSTEOMED SBF SYSTEM (SBF)?

The FDA product code for OSTEOMED SBF SYSTEM (SBF) is DZL.

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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: DZL)

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.

K254286Guided Bone Regeneration SystemDentalMaster(Xiamen)Medical Technology Co., Ltd.K250123Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)Hager& Meisinger GmbHK251569Bone ScrewOsstem Implant Co., Ltd.K243190USTOMED Bone Fixation/Bone Augmentation Systems - PINUstomed Instrumente Ulrich Storz GmbH & Co. KGK233419GBR SystemProimtech Saglik Urunleri Anonim SirketiK240321MP Pin flat without thread (36BMP000020/MP20)Hager& Meisinger GmbH

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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