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FDA 510(k)

ARTHROPLANE

K-Number: K932869 · 1994-03-25

ApplicantSynvasive Technology, Inc.
Decision Date1994-03-25
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHROPLANE is the device name listed in this FDA 510(k) record. The listed applicant is Synvasive Technology, Inc.. It received FDA 510(k) clearance on 1994-03-25 under 510(k) number K932869. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHROPLANE?

ARTHROPLANE is a medical device that received FDA 510(k) clearance on 1994-03-25. The listed applicant is Synvasive Technology, Inc.. The 510(k) number is K932869.

When did ARTHROPLANE receive FDA 510(k) clearance?

ARTHROPLANE received FDA 510(k) clearance on 1994-03-25, under 510(k) number K932869.

Who is the listed applicant for ARTHROPLANE?

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

What is the FDA product code for ARTHROPLANE?

The FDA product code for ARTHROPLANE is HRX.

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Other records listing Synvasive Technology, 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.

K093046ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZESK070108ELIBRA DYNAMIC KNEE BALANCERK972508SURGICAL BURS AND SURGICAL DRILL BITSK961522KIRSCHNER WIRE (K-WIRE) AND STEINMANN PINK950009POWERGRIP(TM) COMPRESSION FIXATION DEVICEK934336SPINALPLANE

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Related Devices (Code: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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