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FDA 510(k)

ISOMETRIC ACL DRILL GUIDE

K-Number: K853762 · 1985-10-07

ApplicantOrthopedic Systems, Inc.
Decision Date1985-10-07
Product CodeGEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ISOMETRIC ACL DRILL GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Systems, Inc.. It received FDA 510(k) clearance on 1985-10-07 under 510(k) number K853762. The device is classified under product code GEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOMETRIC ACL DRILL GUIDE?

ISOMETRIC ACL DRILL GUIDE is a medical device that received FDA 510(k) clearance on 1985-10-07. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K853762.

When did ISOMETRIC ACL DRILL GUIDE receive FDA 510(k) clearance?

ISOMETRIC ACL DRILL GUIDE received FDA 510(k) clearance on 1985-10-07, under 510(k) number K853762.

Who is the listed applicant for ISOMETRIC ACL DRILL GUIDE?

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

What is the FDA product code for ISOMETRIC ACL DRILL GUIDE?

The FDA product code for ISOMETRIC ACL DRILL GUIDE is GEY.

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Other records listing Orthopedic Systems, 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.

K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMK920256SPINE MOTION ANALYZER WITH EMGK910736JACKSON MULTIPURPOSE OPERATING TABLEK910031PARK CITY SHOULDER POSITIONERK903938C FIT CUPK892503NUFFIELD TOTAL KNEE

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Related Devices (Code: GEY)

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.

K050519ADVANCED TURBO DRIVE SYSTEMLinvatec Corp.K020621ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDSArthrocare Corp.K012738SYMPHONY GRAFT DELIVERY SYSTEM (GDS)DepuyacromedK972308MEDNEXT 1000 DRILLMednext, Inc.K971941AQUA SPRAYBoyd Industries, Inc.K971782BONE AND MARROW COLLECTION SYSTEM KITBiomedical Ent., 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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