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FDA 510(k)

BONE CUTTING INSTRUMENTS & ACCESSORIES

K-Number: K874961 · 1987-12-30

ApplicantSolway, Inc.
Decision Date1987-12-30
Product CodeGDR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BONE CUTTING INSTRUMENTS & ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Solway, Inc.. It received FDA 510(k) clearance on 1987-12-30 under 510(k) number K874961. The device is classified under product code GDR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONE CUTTING INSTRUMENTS & ACCESSORIES?

BONE CUTTING INSTRUMENTS & ACCESSORIES is a medical device that received FDA 510(k) clearance on 1987-12-30. The listed applicant is Solway, Inc.. The 510(k) number is K874961.

When did BONE CUTTING INSTRUMENTS & ACCESSORIES receive FDA 510(k) clearance?

BONE CUTTING INSTRUMENTS & ACCESSORIES received FDA 510(k) clearance on 1987-12-30, under 510(k) number K874961.

Who is the listed applicant for BONE CUTTING INSTRUMENTS & ACCESSORIES?

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

What is the FDA product code for BONE CUTTING INSTRUMENTS & ACCESSORIES?

The FDA product code for BONE CUTTING INSTRUMENTS & ACCESSORIES is GDR.

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Other records listing Solway, 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.

K874960CARDIOVASCULAR SURGICAL INSTRUMENTSK874962FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULASK874956SELF-RETAINING RETRACTOR FOR NEUROSURGERYK874964DENTAL HAND INSTRUMENTSK875043RONGEUR (NEUROSURGICAL INSTRUMENTS)K874966TUNING FORKS

View all 13 devices →

Related Devices (Code: GDR)

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.

K85178727-100 TO 29-130 VARIOUS BONE SAWS-CHARRIERE, SATTArtiberia

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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