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FDA 510(k)

SILICONE ELASTOMER MALAR IMPLANT

K-Number: K952707 · 1995-08-28

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

Device Summary

SILICONE ELASTOMER MALAR IMPLANT 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 K952707. 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 SILICONE ELASTOMER MALAR IMPLANT?

SILICONE ELASTOMER MALAR IMPLANT 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 K952707.

When did SILICONE ELASTOMER MALAR IMPLANT receive FDA 510(k) clearance?

SILICONE ELASTOMER MALAR IMPLANT received FDA 510(k) clearance on 1995-08-28, under 510(k) number K952707.

Who is the listed applicant for SILICONE ELASTOMER MALAR IMPLANT?

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 SILICONE ELASTOMER MALAR IMPLANT?

The FDA product code for SILICONE ELASTOMER MALAR IMPLANT is FZE.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 IMPLANTK952706SPIRIT RIDGE SILICONE CARVING BLOCKK952708PECTORALIS IMPLANTK952709PROTHESIS, CHIN, INTERNAL

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

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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