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FDA 510(k)

PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM

K-Number: K952687 · 1996-02-06

ApplicantETHICON, Inc.
Decision Date1996-02-06
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 1996-02-06 under 510(k) number K952687. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM?

PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM is a medical device that received FDA 510(k) clearance on 1996-02-06. The listed applicant is ETHICON, Inc.. The 510(k) number is K952687.

When did PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM receive FDA 510(k) clearance?

PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM received FDA 510(k) clearance on 1996-02-06, under 510(k) number K952687.

Who is the listed applicant for PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM?

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

What is the FDA product code for PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM?

The FDA product code for PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM is MAI.

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Other records listing ETHICON, Inc. as applicant

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Related Devices (Code: MAI)

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.

K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K260294SF Push-in AnchorSurgical Fusion Technologies GmbHK254055OSSIOfiber® Suture AnchorOSSIO , Ltd.K251680Biosteon® ScrewBiocomposites, Ltd.K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation

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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