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FDA 510(k)

MEDPOR SURGICAL GRANULE IMPLANTS

K-Number: K982040 · 1998-09-08

ApplicantPorex Surgical, Inc.
Decision Date1998-09-08
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MEDPOR SURGICAL GRANULE IMPLANTS is the device name listed in this FDA 510(k) record. The listed applicant is Porex Surgical, Inc.. It received FDA 510(k) clearance on 1998-09-08 under 510(k) number K982040. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDPOR SURGICAL GRANULE IMPLANTS?

MEDPOR SURGICAL GRANULE IMPLANTS is a medical device that received FDA 510(k) clearance on 1998-09-08. The listed applicant is Porex Surgical, Inc.. The 510(k) number is K982040.

When did MEDPOR SURGICAL GRANULE IMPLANTS receive FDA 510(k) clearance?

MEDPOR SURGICAL GRANULE IMPLANTS received FDA 510(k) clearance on 1998-09-08, under 510(k) number K982040.

Who is the listed applicant for MEDPOR SURGICAL GRANULE IMPLANTS?

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

What is the FDA product code for MEDPOR SURGICAL GRANULE IMPLANTS?

The FDA product code for MEDPOR SURGICAL GRANULE IMPLANTS is GXP.

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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.

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Other records listing Porex Surgical, 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.

K102184MEDPOR CONTAIN CAN IMPLANTK101835MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079K091807MEDPOR FIXATION SYSTEMK091120MEDPOR CONTAIN IMPLANTK083621MEDPOR CUSTOMIZED SURGICAL IMPLANTK071335MEDPOR ATTRACTOR IMPLANT

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Related Devices (Code: GXP)

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.

K251959TnR Cranial ImplantT&R BIOFAB CO., Ltd.K261265Permatage XT Settable Bone PuttyOrthocon, Inc.K253732Permatage Flowable, Settable Bone PasteOrthocon, Inc.K253854MONTAGE XT Cranial CementOrthocon, Inc.K241027Permatage Settable Bone PuttyOrthocon, Inc.K232771Montage Flowable Settable, Resorbable Bone PasteOrthocon, Inc.

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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