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FDA 510(k)

ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM

K-Number: K952495 · 1996-01-22

ApplicantOrthopedic Systems, Inc.
Decision Date1996-01-22
Product CodeLXH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM 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 1996-01-22 under 510(k) number K952495. The device is classified under product code LXH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM?

ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1996-01-22. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K952495.

When did ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM receive FDA 510(k) clearance?

ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM received FDA 510(k) clearance on 1996-01-22, under 510(k) number K952495.

Who is the listed applicant for ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM?

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 ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM?

The FDA product code for ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM is LXH.

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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.

K920256SPINE MOTION ANALYZER WITH EMGK910736JACKSON MULTIPURPOSE OPERATING TABLEK910031PARK CITY SHOULDER POSITIONERK903938C FIT CUPK892503NUFFIELD TOTAL KNEEK896678SILICONE PLUG

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Related Devices (Code: LXH)

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.

K192873SX-One MicroKnifeSonex Health, Inc.K101609SELF RETAINING SOFT TISSUE RETRACTORKoros USA, Inc.K001507MICROPERFORATION INSTRUMENTSmith & Nephew, Inc.K943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYOrthomet, Inc.K944188SPINAL MARKERLeibinger L.P.K941896STEADMAN LIGAMENT GRAFT PASSER AND PROTECTORDepuy, 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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