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FDA 510(k)

BLAKEMORE RETAINER

K-Number: K880253 · 1988-03-11

ApplicantOrthopedic Systems, Inc.
Decision Date1988-03-11
Product CodeFEF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BLAKEMORE RETAINER 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 1988-03-11 under 510(k) number K880253. The device is classified under product code FEF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLAKEMORE RETAINER?

BLAKEMORE RETAINER is a medical device that received FDA 510(k) clearance on 1988-03-11. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K880253.

When did BLAKEMORE RETAINER receive FDA 510(k) clearance?

BLAKEMORE RETAINER received FDA 510(k) clearance on 1988-03-11, under 510(k) number K880253.

Who is the listed applicant for BLAKEMORE RETAINER?

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 BLAKEMORE RETAINER?

The FDA product code for BLAKEMORE RETAINER is FEF.

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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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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.

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