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FDA 510(k)

BII-PORE(TM) CANAL WALL PROSTHESIS

K-Number: K934049 · 1994-07-19

ApplicantBio-Interfaces, Inc.
Decision Date1994-07-19
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BII-PORE(TM) CANAL WALL PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Interfaces, Inc.. It received FDA 510(k) clearance on 1994-07-19 under 510(k) number K934049. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BII-PORE(TM) CANAL WALL PROSTHESIS?

BII-PORE(TM) CANAL WALL PROSTHESIS is a medical device that received FDA 510(k) clearance on 1994-07-19. The listed applicant is Bio-Interfaces, Inc.. The 510(k) number is K934049.

When did BII-PORE(TM) CANAL WALL PROSTHESIS receive FDA 510(k) clearance?

BII-PORE(TM) CANAL WALL PROSTHESIS received FDA 510(k) clearance on 1994-07-19, under 510(k) number K934049.

Who is the listed applicant for BII-PORE(TM) CANAL WALL PROSTHESIS?

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

What is the FDA product code for BII-PORE(TM) CANAL WALL PROSTHESIS?

The FDA product code for BII-PORE(TM) CANAL WALL PROSTHESIS is LYC.

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Other records listing Bio-Interfaces, 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.

K960164BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140K954763BIO-INTERFACES, INC,. BII-PLASTK950598BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFTK950567BIO-APATITE 6140 HA PARTICLESK950511BLL-FIL 6140 PARTICLESK933688BII-PORE

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Related Devices (Code: LYC)

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.

K253317Cytrans™ ElashieldGC America, Inc.K253883Bonalive MaxillofacialBonalive , Ltd.K251818BONTREE PLUSHudens Bio Co., Ltd.K244006FG Bone Graft MFull Golden Biotech Co., Ltd.K243745FG Bone Graft BFull Golden Biotech CorporationK241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.

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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