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FDA 510(k)

INFILL GRAFT DELIVERY SYSTEM

K-Number: K121476 · 2012-08-29

ApplicantPinnacle Spine Group, LLC
Decision Date2012-08-29
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFILL GRAFT DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pinnacle Spine Group, LLC. It received FDA 510(k) clearance on 2012-08-29 under 510(k) number K121476. 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 INFILL GRAFT DELIVERY SYSTEM?

INFILL GRAFT DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-08-29. The listed applicant is Pinnacle Spine Group, LLC. The 510(k) number is K121476.

When did INFILL GRAFT DELIVERY SYSTEM receive FDA 510(k) clearance?

INFILL GRAFT DELIVERY SYSTEM received FDA 510(k) clearance on 2012-08-29, under 510(k) number K121476.

Who is the listed applicant for INFILL GRAFT DELIVERY SYSTEM?

The FDA 510(k) record lists Pinnacle Spine Group, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFILL GRAFT DELIVERY SYSTEM?

The FDA product code for INFILL GRAFT DELIVERY SYSTEM is FMF.

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Other records listing Pinnacle Spine Group, LLC 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.

K172349InFill® Interbody Fusion DeviceK124012INFILL OBLIQUE TLIF DEVICEK121733INFILL INTERVERTEBRAL BODY FUSION DEVICEK111632INFILL GRAFT DELIVERY SYSTEMK103729INFILL INTERVERTEBRAL BODY FUSION DEVICE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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