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FDA 510(k)

ACUMED BONE GRAFT SYSTEM

K-Number: K960711 · 1996-05-07

ApplicantAcu Med, Inc.
Decision Date1996-05-07
Product CodeKIJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACUMED BONE GRAFT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Acu Med, Inc.. It received FDA 510(k) clearance on 1996-05-07 under 510(k) number K960711. 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 ACUMED BONE GRAFT SYSTEM?

ACUMED BONE GRAFT SYSTEM is a medical device that received FDA 510(k) clearance on 1996-05-07. The listed applicant is Acu Med, Inc.. The 510(k) number is K960711.

When did ACUMED BONE GRAFT SYSTEM receive FDA 510(k) clearance?

ACUMED BONE GRAFT SYSTEM received FDA 510(k) clearance on 1996-05-07, under 510(k) number K960711.

Who is the listed applicant for ACUMED BONE GRAFT SYSTEM?

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

What is the FDA product code for ACUMED BONE GRAFT SYSTEM?

The FDA product code for ACUMED BONE GRAFT SYSTEM is KIJ.

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Other records listing Acu Med, 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.

K021321WRIST FUSION PLATEK013616POLARUS CAP SCREWK012655CONGRUENT BONE PLATE SYSTEMK992525ACUMED MODULAR SHOULDER SYSTEMK993657ACUMED SUTURE ANCHORK980103ACUMED SUTURE ANCHOR

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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.K951450SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERYStrenumed, 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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