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FDA 510(k)

ACE SUPRACONDYLAR PLATE

K-Number: K950618 · 1995-05-10

ApplicantAce Medical Co.
Decision Date1995-05-10
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACE SUPRACONDYLAR PLATE 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 1995-05-10 under 510(k) number K950618. 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 SUPRACONDYLAR PLATE?

ACE SUPRACONDYLAR PLATE is a medical device that received FDA 510(k) clearance on 1995-05-10. The listed applicant is Ace Medical Co.. The 510(k) number is K950618.

When did ACE SUPRACONDYLAR PLATE receive FDA 510(k) clearance?

ACE SUPRACONDYLAR PLATE received FDA 510(k) clearance on 1995-05-10, under 510(k) number K950618.

Who is the listed applicant for ACE SUPRACONDYLAR PLATE?

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 SUPRACONDYLAR PLATE?

The FDA product code for ACE SUPRACONDYLAR PLATE 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 NAILK955472ACE HUMERUS & RADIUS PLATESK955388ACE-DUPONT COMPOSITE RINGSK9544856.5MM SOLID CANCELLOUS BONE SCREWK954069ACE CERVICAL TRACTION HALOZS, TONGS & PINSK933968ACE 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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