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)

ALIGNMENT INSTRUMENT

K-Number: K970345 · 1997-04-29

ApplicantRichard Wolf Medical Instruments Corp.
Decision Date1997-04-29
Product CodeHSZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALIGNMENT INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 1997-04-29 under 510(k) number K970345. The device is classified under product code HSZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALIGNMENT INSTRUMENT?

ALIGNMENT INSTRUMENT is a medical device that received FDA 510(k) clearance on 1997-04-29. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K970345.

When did ALIGNMENT INSTRUMENT receive FDA 510(k) clearance?

ALIGNMENT INSTRUMENT received FDA 510(k) clearance on 1997-04-29, under 510(k) number K970345.

Who is the listed applicant for ALIGNMENT INSTRUMENT?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALIGNMENT INSTRUMENT?

The FDA product code for ALIGNMENT INSTRUMENT is HSZ.

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 Richard Wolf Medical Instruments Corp. 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.

K151282core nova Complete Operating Room EndoscopyK130423THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525K121724ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2K120898KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CAK090776MEGAPULSE LASER SYSTEM AND FIBERSK080617POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES

View all 142 devices →

Related Devices (Code: HSZ)

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.

K991588EMS SWISS ORTHOCLAST(Ems Sa) Electro Medical SystemsK972860CURVTEK TSR SYSTEMBiolectron, Inc.K955084ASPACH 65,000 (MODIFICATION)The Anspach Effort, Inc.K954080SODEM HIGH SPEED SYSTEMSodem Diffusion SAK944590ETHICON DRILL BIT AND DRILL GUIDEETHICON, Inc.K934336SPINALPLANESynvasive Technology, 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.

↑