FDA 510(k)

DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI

K-Number: K974245 · 1998-05-22

Decision Date1998-05-22

Product CodeLXT

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ace Medical Co.. It received FDA 510(k) clearance on 1998-05-22 under 510(k) number K974245. The device is classified under product code LXT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI?

DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI is a medical device that received FDA 510(k) clearance on 1998-05-22. The listed applicant is Depuy Ace Medical Co.. The 510(k) number is K974245.

When did DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI receive FDA 510(k) clearance?

DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI received FDA 510(k) clearance on 1998-05-22, under 510(k) number K974245.

Who is the listed applicant for DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI?

The FDA 510(k) record lists Depuy Ace Medical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI?

The FDA product code for DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI is LXT.

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Other records listing Depuy Ace Medical Co. as applicant

K990392DEPUY ACE SPIDER PLATE K990120MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE K984458DEPUY ACE SPIDER PLATE K983853DEPUY ACE TIMAX META PLATE K983265DEPUY ACE COMPOSITE LOCKING NUT K982347DEPUY ACE TIMAX PILON PLATE

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Related Devices (Code: LXT)

K230067Para-Fix External Fixation SystemNew Paradigm Biomedical K131636POLARUS CONNECTAcumed, LLC K132704DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROWBiomet K112345DISTAL VOLAR RADIUS PLATING SYSTEMSMedos International SARL K090374STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(SDePuy Orthopaedics, Inc.K073135SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONSSynthes (Usa)

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.