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FDA 510(k)

PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW

K-Number: K982900 · 1998-08-31

ApplicantDepuy, Inc.
Decision Date1998-08-31
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1998-08-31 under 510(k) number K982900. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW?

PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW is a medical device that received FDA 510(k) clearance on 1998-08-31. The listed applicant is Depuy, Inc.. The 510(k) number is K982900.

When did PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW receive FDA 510(k) clearance?

PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW received FDA 510(k) clearance on 1998-08-31, under 510(k) number K982900.

Who is the listed applicant for PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW?

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

What is the FDA product code for PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW?

The FDA product code for PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW is MAI.

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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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