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FDA 510(k)

ARTHREX GRAFT HARVESTING KIT

K-Number: K941285 · 1994-11-14

ApplicantArthrex, Inc.
Decision Date1994-11-14
Product CodeKIJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARTHREX GRAFT HARVESTING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 1994-11-14 under 510(k) number K941285. The device is classified under product code KIJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHREX GRAFT HARVESTING KIT?

ARTHREX GRAFT HARVESTING KIT is a medical device that received FDA 510(k) clearance on 1994-11-14. The listed applicant is Arthrex, Inc.. The 510(k) number is K941285.

When did ARTHREX GRAFT HARVESTING KIT receive FDA 510(k) clearance?

ARTHREX GRAFT HARVESTING KIT received FDA 510(k) clearance on 1994-11-14, under 510(k) number K941285.

Who is the listed applicant for ARTHREX GRAFT HARVESTING KIT?

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

What is the FDA product code for ARTHREX GRAFT HARVESTING KIT?

The FDA product code for ARTHREX GRAFT HARVESTING KIT is KIJ.

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Other records listing Arthrex, 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.

K262975Arthrex Beaming SystemK262618Arthrex Spine Compression FT ScrewK262451Arthrex DynaNite StaplesK262357Arthrex Bioabsorbable PushLock Suture AnchorsK260624Arthrex Radial Head Replacement SystemK260018Arthrex FiberButton

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Related Devices (Code: KIJ)

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.

K163308SMARTOJeil Medical CorporationK112599INSURGICAL SINGLE USE POWER EQUIPMENTInsurgical, LLCK101563SMARTOJeil Medical CorporationK972367STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENTStryker InstrumentsK970378STRYKER 2115 REPLACEMENT BATTERY (2115)Implant Resource, Inc.K960711ACUMED BONE GRAFT SYSTEMAcu Med, Inc.

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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