FDA 510(k)

BONE BAND

K-Number: K983685 · 1998-12-04

Decision Date1998-12-04

Product CodeLYT

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

BONE BAND is the device name listed in this FDA 510(k) record. The listed applicant is Chapel and Assoc.. It received FDA 510(k) clearance on 1998-12-04 under 510(k) number K983685. The device is classified under product code LYT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONE BAND?

BONE BAND is a medical device that received FDA 510(k) clearance on 1998-12-04. The listed applicant is Chapel and Assoc.. The 510(k) number is K983685.

When did BONE BAND receive FDA 510(k) clearance?

BONE BAND received FDA 510(k) clearance on 1998-12-04, under 510(k) number K983685.

Who is the listed applicant for BONE BAND?

The FDA 510(k) record lists Chapel and Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BONE BAND?

The FDA product code for BONE BAND is LYT.

Related Devices (Code: LYT)

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.

K040363CERAMIC TIPPED SKULL PINThe Jerome Group, Inc.K980594OSTEONICS FX-CABLELOK GRIP COMPONENTSOsteonics Corp.K914812K-CAP-E, STERILEWestcon Orthopedics, Inc.K912762K-CAP-I, STERILEWestcon Orthopedics, Inc.K902053K-CAP-I ORTHOPEDIC FIXATION WIRE CAPWestcon Orthopedics, Inc.K902676MICROGUARD, ORTHOPEDIC PIN PROTECTORSMicro-Aire Surgical Instruments, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.