Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT

K-Number: K942420 · 1994-08-08

ApplicantKing & Spalding
Decision Date1994-08-08
Product CodeLZK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is King & Spalding. It received FDA 510(k) clearance on 1994-08-08 under 510(k) number K942420. The device is classified under product code LZK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT?

IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT is a medical device that received FDA 510(k) clearance on 1994-08-08. The listed applicant is King & Spalding. The 510(k) number is K942420.

When did IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT receive FDA 510(k) clearance?

IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT received FDA 510(k) clearance on 1994-08-08, under 510(k) number K942420.

Who is the listed applicant for IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT?

The FDA 510(k) record lists King & Spalding as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT?

The FDA product code for IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT is LZK.

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 King & Spalding 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.

K942423NAIS WRIST BLOOD PRESSURE METERK942422PANASONIC WRIST BLOOD PRESSURE METERK945998CHIN IMPLANT STYLE IK944408IMPLANTECH MEDICAL GRADE SILICONE SHEETINGK942421IMPLANTECH LATERAL MANDIBULAR BAR IMPLANTK941972HEMO-O-LOK

View all 7 devices →

Related Devices (Code: LZK)

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.

K021419AART MALAR IMPLANTAesthetic and Reconstructive Technologies, Inc.K002886IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)Implantech Associates, Inc.K992240PILLAR MALAR IMPLANTPillar Surgical, Inc.K983756SURGIFORM ANATOMICAL MALARSurgical Technology Laboratories, Inc.K982763SEARE BIOMEDICAL MALAR IMPLANTSSeare Biomedical Corp.K981835SILIMED MALAR IMPLANTSilimed, LLC

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.

↑