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FDA 510(k)

ORTHOPEDIC SMOOTH PIN FIXATION

K-Number: K932348 · 1994-03-01

ApplicantOsteomed Corp.
Decision Date1994-03-01
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOPEDIC SMOOTH PIN FIXATION is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed Corp.. It received FDA 510(k) clearance on 1994-03-01 under 510(k) number K932348. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOPEDIC SMOOTH PIN FIXATION?

ORTHOPEDIC SMOOTH PIN FIXATION is a medical device that received FDA 510(k) clearance on 1994-03-01. The listed applicant is Osteomed Corp.. The 510(k) number is K932348.

When did ORTHOPEDIC SMOOTH PIN FIXATION receive FDA 510(k) clearance?

ORTHOPEDIC SMOOTH PIN FIXATION received FDA 510(k) clearance on 1994-03-01, under 510(k) number K932348.

Who is the listed applicant for ORTHOPEDIC SMOOTH PIN FIXATION?

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

What is the FDA product code for ORTHOPEDIC SMOOTH PIN FIXATION?

The FDA product code for ORTHOPEDIC SMOOTH PIN FIXATION is HTY.

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Other records listing Osteomed Corp. 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.

K022277OSTEOMED CRANIAL FLAP FIXATION SYSTEMK022887INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMK022886METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMK0232601.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEMK013618INTRAORAL MANDIBULAR DISTRACTION SYSTEMK021618OSA RIGID INTERNAL FIXATION SYSTEM

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Related Devices (Code: HTY)

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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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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