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FDA 510(k)

SYNTHES HEMOSTATIC BONE PUTTY (HBP)

K-Number: K103822 · 2011-05-19

ApplicantSynthes USA Products, LLC
Decision Date2011-05-19
Product CodeMTJ
DecisionSubstantially Equivalent

Device Summary

SYNTHES HEMOSTATIC BONE PUTTY (HBP) is the device name listed in this FDA 510(k) record. The listed applicant is Synthes USA Products, LLC. It received FDA 510(k) clearance on 2011-05-19 under 510(k) number K103822. The device is classified under product code MTJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES HEMOSTATIC BONE PUTTY (HBP)?

SYNTHES HEMOSTATIC BONE PUTTY (HBP) is a medical device that received FDA 510(k) clearance on 2011-05-19. The listed applicant is Synthes USA Products, LLC. The 510(k) number is K103822.

When did SYNTHES HEMOSTATIC BONE PUTTY (HBP) receive FDA 510(k) clearance?

SYNTHES HEMOSTATIC BONE PUTTY (HBP) received FDA 510(k) clearance on 2011-05-19, under 510(k) number K103822.

Who is the listed applicant for SYNTHES HEMOSTATIC BONE PUTTY (HBP)?

The FDA 510(k) record lists Synthes USA Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTHES HEMOSTATIC BONE PUTTY (HBP)?

The FDA product code for SYNTHES HEMOSTATIC BONE PUTTY (HBP) is MTJ.

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Related Devices (Code: MTJ)

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.

K262769Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)Orthocon, Inc.K261439Permatage Flowable, Settable Hemostatic Bone PasteOrthocon, Inc.K232998Montage- XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.K213418MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.K231386Montage Flowable XRO Settable, Resorbable Hemostatic Bone PasteOrthocon, Inc.K200452Meril-BonewaxM/s. Meril Endo Surgery Private Limited.

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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