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FDA 510(k)

HARD TISSUE REPLACEMENT (HTR) GRANULAR

K-Number: K934861 · 1994-11-04

ApplicantPoly-Medics,Inc.
Decision Date1994-11-04
Product CodeKKY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HARD TISSUE REPLACEMENT (HTR) GRANULAR is the device name listed in this FDA 510(k) record. The listed applicant is Poly-Medics,Inc.. It received FDA 510(k) clearance on 1994-11-04 under 510(k) number K934861. 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 HARD TISSUE REPLACEMENT (HTR) GRANULAR?

HARD TISSUE REPLACEMENT (HTR) GRANULAR is a medical device that received FDA 510(k) clearance on 1994-11-04. The listed applicant is Poly-Medics,Inc.. The 510(k) number is K934861.

When did HARD TISSUE REPLACEMENT (HTR) GRANULAR receive FDA 510(k) clearance?

HARD TISSUE REPLACEMENT (HTR) GRANULAR received FDA 510(k) clearance on 1994-11-04, under 510(k) number K934861.

Who is the listed applicant for HARD TISSUE REPLACEMENT (HTR) GRANULAR?

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

What is the FDA product code for HARD TISSUE REPLACEMENT (HTR) GRANULAR?

The FDA product code for HARD TISSUE REPLACEMENT (HTR) GRANULAR is KKY.

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Other records listing Poly-Medics,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.

K960988LACTOSORB TRAUMA PLATING SYSTEMK955729LACTOSORB TRAUMA PLATING SYSTEMK954443LACTOSORB SUTURE ANCHORK951658LACTOSORB POP RIVET

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

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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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