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FDA 510(k)

BOW & ARROW DRILL GUIDE

K-Number: K882407 · 1988-09-06

ApplicantInstrument Makar, Inc.
Decision Date1988-09-06
Product CodeLXI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BOW & ARROW DRILL GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Instrument Makar, Inc.. It received FDA 510(k) clearance on 1988-09-06 under 510(k) number K882407. The device is classified under product code LXI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOW & ARROW DRILL GUIDE?

BOW & ARROW DRILL GUIDE is a medical device that received FDA 510(k) clearance on 1988-09-06. The listed applicant is Instrument Makar, Inc.. The 510(k) number is K882407.

When did BOW & ARROW DRILL GUIDE receive FDA 510(k) clearance?

BOW & ARROW DRILL GUIDE received FDA 510(k) clearance on 1988-09-06, under 510(k) number K882407.

Who is the listed applicant for BOW & ARROW DRILL GUIDE?

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

What is the FDA product code for BOW & ARROW DRILL GUIDE?

The FDA product code for BOW & ARROW DRILL GUIDE is LXI.

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Other records listing Instrument Makar, 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.

K002600LITWIN CRUICATE ANCHORK980999ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANTK963396BIOSPHERE SUTURE ANCHORK964364DISPOSABLE APRONK955835FLUID BARRIER BOOT KNEE & ANKLE-HIGHK960555BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR

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Related Devices (Code: LXI)

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.

K930573SYNVASIVE CERAMIC SUTTING BLOCKSynvasive Technology, Inc.K910712VILLAN (VIDEO LIFT LINK ANALYSIS)Physio Systems, Inc.K892655ACL DRILL GUIDE SYSTEMBaxter Healthcare CorpK890445PERSONAL ALERT ASSIST DEVICESilent Call Corp.K881378PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDEPfizer, Inc.K880739DYONICS DRILL GUIDE/ISOMETER SYSTEMDyonics, 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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