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FDA 510(k)

PROTHESIS, CHIN, INTERNAL

K-Number: K952709 · 1995-08-28

ApplicantSpirit Ridge Technologies
Decision Date1995-08-28
Product CodeFZE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROTHESIS, CHIN, INTERNAL is the device name listed in this FDA 510(k) record. The listed applicant is Spirit Ridge Technologies. It received FDA 510(k) clearance on 1995-08-28 under 510(k) number K952709. The device is classified under product code FZE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTHESIS, CHIN, INTERNAL?

PROTHESIS, CHIN, INTERNAL is a medical device that received FDA 510(k) clearance on 1995-08-28. The listed applicant is Spirit Ridge Technologies. The 510(k) number is K952709.

When did PROTHESIS, CHIN, INTERNAL receive FDA 510(k) clearance?

PROTHESIS, CHIN, INTERNAL received FDA 510(k) clearance on 1995-08-28, under 510(k) number K952709.

Who is the listed applicant for PROTHESIS, CHIN, INTERNAL?

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

What is the FDA product code for PROTHESIS, CHIN, INTERNAL?

The FDA product code for PROTHESIS, CHIN, INTERNAL is FZE.

Related Clinical Trials

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Other records listing Spirit Ridge Technologies 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.

K952705SPIRIT RIDGE NASAL IMPLANTK952707SILICONE ELASTOMER MALAR IMPLANTK952706SPIRIT RIDGE SILICONE CARVING BLOCKK952708PECTORALIS IMPLANT

Related Devices (Code: FZE)

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.

K241253Medicon Epiplating SystemCmf Medicon Surgical, Inc.K161548Osseointegrated FixturesSouthern Implants (Pty), Ltd.K090803HANSON MEDICAL FACIAL IMPLANTSHanson Medical, Inc.K090630NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)Nobel Biocare ABK071018MONARCH NASAL IMPLANTHanson Medical, Inc.K041690MONARCH NASAL IMPLANTHanson Medical, Inc.

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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