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FDA 510(k)

INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES

K-Number: K970705 · 1997-05-22

ApplicantSulzer Orthopedics, Inc.
Decision Date1997-05-22
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES is the device name listed in this FDA 510(k) record. The listed applicant is Sulzer Orthopedics, Inc.. It received FDA 510(k) clearance on 1997-05-22 under 510(k) number K970705. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES?

INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES is a medical device that received FDA 510(k) clearance on 1997-05-22. The listed applicant is Sulzer Orthopedics, Inc.. The 510(k) number is K970705.

When did INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES receive FDA 510(k) clearance?

INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES received FDA 510(k) clearance on 1997-05-22, under 510(k) number K970705.

Who is the listed applicant for INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES?

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

What is the FDA product code for INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES?

The FDA product code for INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES is LPH.

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Other records listing Sulzer Orthopedics, Inc. as applicant

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Related Devices (Code: LPH)

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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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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