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FDA 510(k)

PROFORM HA HIP SYSTEM

K-Number: K934162 · 1994-03-09

ApplicantStelkast Company
Decision Date1994-03-09
Product CodeJDO
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

PROFORM HA HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stelkast Company. It received FDA 510(k) clearance on 1994-03-09 under 510(k) number K934162. The device is classified under product code JDO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the PROFORM HA HIP SYSTEM?

PROFORM HA HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1994-03-09. The listed applicant is Stelkast Company. The 510(k) number is K934162.

When did PROFORM HA HIP SYSTEM receive FDA 510(k) clearance?

PROFORM HA HIP SYSTEM received FDA 510(k) clearance on 1994-03-09, under 510(k) number K934162.

Who is the listed applicant for PROFORM HA HIP SYSTEM?

The FDA 510(k) record lists Stelkast Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROFORM HA HIP SYSTEM?

The FDA product code for PROFORM HA HIP SYSTEM is JDO.

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Other records listing Stelkast Company 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.

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Related Devices (Code: JDO)

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.

K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric TechnologiesK213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screwsSmith & Nephew, Inc.K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric TraumaK193029CONQUEST FNSmith & Nephew, Inc.K173826THP Hip Fracture Plating SystemBiomet, Inc.K172785CONQUEST FNSmith & Nephew

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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