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FDA 510(k)

SGARLATO LESSER TOE IMPLANT

K-Number: K884739 · 1989-05-18

ApplicantSgarlato Laboratories, Inc.
Decision Date1989-05-18
Product CodeKWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SGARLATO LESSER TOE IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Sgarlato Laboratories, Inc.. It received FDA 510(k) clearance on 1989-05-18 under 510(k) number K884739. The device is classified under product code KWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SGARLATO LESSER TOE IMPLANT?

SGARLATO LESSER TOE IMPLANT is a medical device that received FDA 510(k) clearance on 1989-05-18. The listed applicant is Sgarlato Laboratories, Inc.. The 510(k) number is K884739.

When did SGARLATO LESSER TOE IMPLANT receive FDA 510(k) clearance?

SGARLATO LESSER TOE IMPLANT received FDA 510(k) clearance on 1989-05-18, under 510(k) number K884739.

Who is the listed applicant for SGARLATO LESSER TOE IMPLANT?

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

What is the FDA product code for SGARLATO LESSER TOE IMPLANT?

The FDA product code for SGARLATO LESSER TOE IMPLANT is KWH.

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Other records listing Sgarlato Laboratories, 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.

K043204SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMPK990101PAIN CONTROL INFUSION PUMPK982931THREADED FIXATION PINK926262FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICEK926237O'BRIEN GONIOMETERK922292LUNDEEN SUBTALAR PEG IMPLANT

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Related Devices (Code: KWH)

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.

K191966NewPrim SystemBrm ExtremitiesK190136Fusion Silastic SystemFusion Orthopedics, LLCK173491RTS Lesser MTP Implant SystemIn2bones USA, LLCK153609RTS Flexible 1 MPJ Implant w/GrommetsIn2bones USA, LLCK102601ORTHOFLEX RODOrtho-Pro, LLCK023531LESSER METATARSAL PHALANGEAL JOINT IMPLANTNexa Orthopedics, 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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