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FDA 510(k)

ORTHADAPT PR

K-Number: K090288 · 2009-05-05

ApplicantPegasus Biologics, Inc.
Decision Date2009-05-05
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ORTHADAPT PR is the device name listed in this FDA 510(k) record. The listed applicant is Pegasus Biologics, Inc.. It received FDA 510(k) clearance on 2009-05-05 under 510(k) number K090288. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHADAPT PR?

ORTHADAPT PR is a medical device that received FDA 510(k) clearance on 2009-05-05. The listed applicant is Pegasus Biologics, Inc.. The 510(k) number is K090288.

When did ORTHADAPT PR receive FDA 510(k) clearance?

ORTHADAPT PR received FDA 510(k) clearance on 2009-05-05, under 510(k) number K090288.

Who is the listed applicant for ORTHADAPT PR?

The FDA 510(k) record lists Pegasus Biologics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHADAPT PR?

The FDA product code for ORTHADAPT PR is FTL.

Related Clinical Trials

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Other records listing Pegasus Biologics, Inc. 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.

K071425UNITE BIOMATRIXK071065ORTHADAPT BIOIMPLANTK061494DERMADAPT WOUND DRESSINGK043388PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH

Related Devices (Code: FTL)

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.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim ProductionK253125Parietene™ Flat Sheet MeshMedtronic - Sofradim ProductionK251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim ProductionK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, Inc.

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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