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FDA 510(k)

OSTEOTOMY BONE STAPLE

K-Number: K830255 · 1983-03-09

ApplicantTechmedica, Inc.
Decision Date1983-03-09
Product CodeHXJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEOTOMY BONE STAPLE is the device name listed in this FDA 510(k) record. The listed applicant is Techmedica, Inc.. It received FDA 510(k) clearance on 1983-03-09 under 510(k) number K830255. The device is classified under product code HXJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEOTOMY BONE STAPLE?

OSTEOTOMY BONE STAPLE is a medical device that received FDA 510(k) clearance on 1983-03-09. The listed applicant is Techmedica, Inc.. The 510(k) number is K830255.

When did OSTEOTOMY BONE STAPLE receive FDA 510(k) clearance?

OSTEOTOMY BONE STAPLE received FDA 510(k) clearance on 1983-03-09, under 510(k) number K830255.

Who is the listed applicant for OSTEOTOMY BONE STAPLE?

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

What is the FDA product code for OSTEOTOMY BONE STAPLE?

The FDA product code for OSTEOTOMY BONE STAPLE is HXJ.

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Other records listing Techmedica, 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.

K933935CKS POROUS COATED FEMORAL COMPONENTK932017TECHMEDICA CONTINUUM HIP WITH HA COATINGK931929TECHMEDICA CONTINUUM HIP SYSTEMK926387TECHMEDICA STANDARD CEMENTED HIP SYSTEMK925420TECHMEDICA STANDARD BIPOLAR SYSTEMK923808MULLER STRAIGHT STEM FEMORAL PROSTHESIS

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Related Devices (Code: HXJ)

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.

K964953IN-TAC BONE ANCHOR SYSTEMInfluence, Inc.K962372UROTAC BONE ANCHOR INSERTERInfluence, Inc.K930205ELECTRIC WIRE DRIVER, MODEL 2640EMicro Surgical Instruments Corp.K834515FIXATION STAPLE KIT - DLIDE HAMMERStryker Corp.K830456STAPLE INSERTER-EXTRACTOR FOR ARTHROSInstrument Makar, 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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