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FDA 510(k)

LUKENS BONE WAX (GAMMA RADIATION)

K-Number: K791495 · 1979-09-24

ApplicantLukens Corp.
Decision Date1979-09-24
Product CodeMTJ
DecisionSubstantially Equivalent

Device Summary

LUKENS BONE WAX (GAMMA RADIATION) is the device name listed in this FDA 510(k) record. The listed applicant is Lukens Corp.. It received FDA 510(k) clearance on 1979-09-24 under 510(k) number K791495. The device is classified under product code MTJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUKENS BONE WAX (GAMMA RADIATION)?

LUKENS BONE WAX (GAMMA RADIATION) is a medical device that received FDA 510(k) clearance on 1979-09-24. The listed applicant is Lukens Corp.. The 510(k) number is K791495.

When did LUKENS BONE WAX (GAMMA RADIATION) receive FDA 510(k) clearance?

LUKENS BONE WAX (GAMMA RADIATION) received FDA 510(k) clearance on 1979-09-24, under 510(k) number K791495.

Who is the listed applicant for LUKENS BONE WAX (GAMMA RADIATION)?

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

What is the FDA product code for LUKENS BONE WAX (GAMMA RADIATION)?

The FDA product code for LUKENS BONE WAX (GAMMA RADIATION) is MTJ.

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Other records listing Lukens 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.

K880230SIXALYZERK800102STANFORD STERILE LAP SPONGESK792471STANFORD STERILE LAP SPONGESK770797TRAY, CATHETERIZATION W/FOLEY, STERILEK770795SHAVE PREP SETK770799TRAY, IRRIGATION, STERILE, BASIC

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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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