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FDA 510(k)

FLOWER SMALL AND MEDIUM IMPLANT SET

K-Number: K131657 · 2013-08-22

ApplicantFlower Orthopedics Corporation
Decision Date2013-08-22
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FLOWER SMALL AND MEDIUM IMPLANT SET is the device name listed in this FDA 510(k) record. The listed applicant is Flower Orthopedics Corporation. It received FDA 510(k) clearance on 2013-08-22 under 510(k) number K131657. 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 FLOWER SMALL AND MEDIUM IMPLANT SET?

FLOWER SMALL AND MEDIUM IMPLANT SET is a medical device that received FDA 510(k) clearance on 2013-08-22. The listed applicant is Flower Orthopedics Corporation. The 510(k) number is K131657.

When did FLOWER SMALL AND MEDIUM IMPLANT SET receive FDA 510(k) clearance?

FLOWER SMALL AND MEDIUM IMPLANT SET received FDA 510(k) clearance on 2013-08-22, under 510(k) number K131657.

Who is the listed applicant for FLOWER SMALL AND MEDIUM IMPLANT SET?

The FDA 510(k) record lists Flower Orthopedics Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLOWER SMALL AND MEDIUM IMPLANT SET?

The FDA product code for FLOWER SMALL AND MEDIUM IMPLANT SET is HRS.

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.

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Other records listing Flower Orthopedics Corporation 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.

K192949Flower Suture Anchor SetK170687Flower Bone Screw SetK133102FLOWER ANKLE PLATING SETK132248FLOWER BONE SCREW SETK123562FLOWER SMALL AND MEDIUM BONE IMPLANTS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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