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FDA 510(k)

TRUGRAFT BGS SYRINGE, MODEL 600-041

K-Number: K043172 · 2005-01-07

ApplicantOsteobiologics, Inc.
Decision Date2005-01-07
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TRUGRAFT BGS SYRINGE, MODEL 600-041 is the device name listed in this FDA 510(k) record. The listed applicant is Osteobiologics, Inc.. It received FDA 510(k) clearance on 2005-01-07 under 510(k) number K043172. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUGRAFT BGS SYRINGE, MODEL 600-041?

TRUGRAFT BGS SYRINGE, MODEL 600-041 is a medical device that received FDA 510(k) clearance on 2005-01-07. The listed applicant is Osteobiologics, Inc.. The 510(k) number is K043172.

When did TRUGRAFT BGS SYRINGE, MODEL 600-041 receive FDA 510(k) clearance?

TRUGRAFT BGS SYRINGE, MODEL 600-041 received FDA 510(k) clearance on 2005-01-07, under 510(k) number K043172.

Who is the listed applicant for TRUGRAFT BGS SYRINGE, MODEL 600-041?

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

What is the FDA product code for TRUGRAFT BGS SYRINGE, MODEL 600-041?

The FDA product code for TRUGRAFT BGS SYRINGE, MODEL 600-041 is FMF.

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Other records listing Osteobiologics, 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.

K051656OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEMK041382POLYGRAFT BGS; BONE GRAFT SUBSTITUTEK040047POLYGRAFT BGS; BONE GRAFT SUBSTITUTEK033707POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XXK032673IMMIX PLASTIFILMK030288POLYGRAFT BONE GRAFT SUBSTITUTE

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Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

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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