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FDA 510(k)

ORTHOPAEDIC WIRES

K-Number: K942603 · 1994-11-09

ApplicantAcu Med, Inc.
Decision Date1994-11-09
Product CodeLRN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOPAEDIC WIRES 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 1994-11-09 under 510(k) number K942603. The device is classified under product code LRN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOPAEDIC WIRES?

ORTHOPAEDIC WIRES is a medical device that received FDA 510(k) clearance on 1994-11-09. The listed applicant is Acu Med, Inc.. The 510(k) number is K942603.

When did ORTHOPAEDIC WIRES receive FDA 510(k) clearance?

ORTHOPAEDIC WIRES received FDA 510(k) clearance on 1994-11-09, under 510(k) number K942603.

Who is the listed applicant for ORTHOPAEDIC WIRES?

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 ORTHOPAEDIC WIRES?

The FDA product code for ORTHOPAEDIC WIRES is LRN.

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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: LRN)

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.

K002755NON-ABSORBING STERNATOMY MONOFILAMENT SUTURET. Korossurgical Instruments Corp.K990355STAINLESS STEEL SOFT SUTURE WIREBregma International Trading Company , Ltd.K971682J-FX CERCLAGE SYSTEMJohnson & Johnson Professionals, Inc.K952783OXBORO-MEDICAL PIN COVERSOxboro Medical Intl., Inc.K900926TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS)Howmedica Corp.K892651SONGER WIRING SYSTEMDanek Medical, 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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