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FDA 510(k)

DEPUY ACE TIMAX PILON PLATE

K-Number: K982347 · 1998-08-31

ApplicantDepuy Ace Medical Co.
Decision Date1998-08-31
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY ACE TIMAX PILON PLATE 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 1998-08-31 under 510(k) number K982347. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPUY ACE TIMAX PILON PLATE?

DEPUY ACE TIMAX PILON PLATE is a medical device that received FDA 510(k) clearance on 1998-08-31. The listed applicant is Depuy Ace Medical Co.. The 510(k) number is K982347.

When did DEPUY ACE TIMAX PILON PLATE receive FDA 510(k) clearance?

DEPUY ACE TIMAX PILON PLATE received FDA 510(k) clearance on 1998-08-31, under 510(k) number K982347.

Who is the listed applicant for DEPUY ACE TIMAX PILON PLATE?

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 TIMAX PILON PLATE?

The FDA product code for DEPUY ACE TIMAX PILON PLATE is HRS.

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Other records listing Depuy Ace Medical Co. 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.

K990392DEPUY ACE SPIDER PLATEK990120MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATEK984458DEPUY ACE SPIDER PLATEK983853DEPUY ACE TIMAX META PLATEK983265DEPUY ACE COMPOSITE LOCKING NUTK981775DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATE

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Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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