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FDA 510(k)

SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)

K-Number: K021889 · 2002-10-16

ApplicantSurgical Technology Laboratories, Inc.
Decision Date2002-10-16
Product CodeKKY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Technology Laboratories, Inc.. It received FDA 510(k) clearance on 2002-10-16 under 510(k) number K021889. The device is classified under product code KKY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)?

SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) is a medical device that received FDA 510(k) clearance on 2002-10-16. The listed applicant is Surgical Technology Laboratories, Inc.. The 510(k) number is K021889.

When did SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) receive FDA 510(k) clearance?

SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) received FDA 510(k) clearance on 2002-10-16, under 510(k) number K021889.

Who is the listed applicant for SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)?

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

What is the FDA product code for SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)?

The FDA product code for SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) is KKY.

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Other records listing Surgical Technology Laboratories, 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.

K170582Saf-T-Vac Smoke and Fluid EvacuatorK983755NASAL DORSAL SERIESK983754STANDARD CHINK983756SURGIFORM ANATOMICAL MALARK964443SURGIFORM ANATOMICAL MALARK840835STRAITH DRAIN INSERTER

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Related Devices (Code: KKY)

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.

K211514Longeviti PorousFit implantLongeviti Neuro Solutions, LLCK161052OsteoFab Patient Specific Facial DeviceOxford Performance Materials, Inc.K160988Biopor, AOC Porous Polyethylene, CereporCeremed , Inc.K123908OMNIPORE SURGICAL IMPLANTS AND ACCESSORIESMatrix Surgical USAK111323SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTSSynthes, Inc.K103010STRYKER PATIENT SPECIFIC POLYMER IMPLANTHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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