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FDA 510(k)

ACE HUMERUS & RADIUS PLATES

K-Number: K955472 · 1996-04-01

ApplicantAce Medical Co.
Decision Date1996-04-01
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACE HUMERUS & RADIUS PLATES is the device name listed in this FDA 510(k) record. The listed applicant is Ace Medical Co.. It received FDA 510(k) clearance on 1996-04-01 under 510(k) number K955472. 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 ACE HUMERUS & RADIUS PLATES?

ACE HUMERUS & RADIUS PLATES is a medical device that received FDA 510(k) clearance on 1996-04-01. The listed applicant is Ace Medical Co.. The 510(k) number is K955472.

When did ACE HUMERUS & RADIUS PLATES receive FDA 510(k) clearance?

ACE HUMERUS & RADIUS PLATES received FDA 510(k) clearance on 1996-04-01, under 510(k) number K955472.

Who is the listed applicant for ACE HUMERUS & RADIUS PLATES?

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

What is the FDA product code for ACE HUMERUS & RADIUS PLATES?

The FDA product code for ACE HUMERUS & RADIUS PLATES is HRS.

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Other records listing 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.

K972183DEPUY ACE A.I.M. TITANIUM TIBIAL NAILK955388ACE-DUPONT COMPOSITE RINGSK9544856.5MM SOLID CANCELLOUS BONE SCREWK954069ACE CERVICAL TRACTION HALOZS, TONGS & PINSK950618ACE SUPRACONDYLAR PLATEK933968ACE PELVIC STABILIZER

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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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