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FDA 510(k)

HEIDELBERG EXTERNAL FIXATOR

K-Number: K970751 · 1997-04-16

ApplicantSmith & Nephew, Inc., Orthopaedic Div.
Decision Date1997-04-16
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEIDELBERG EXTERNAL FIXATOR is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc., Orthopaedic Div.. It received FDA 510(k) clearance on 1997-04-16 under 510(k) number K970751. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEIDELBERG EXTERNAL FIXATOR?

HEIDELBERG EXTERNAL FIXATOR is a medical device that received FDA 510(k) clearance on 1997-04-16. The listed applicant is Smith & Nephew, Inc., Orthopaedic Div.. The 510(k) number is K970751.

When did HEIDELBERG EXTERNAL FIXATOR receive FDA 510(k) clearance?

HEIDELBERG EXTERNAL FIXATOR received FDA 510(k) clearance on 1997-04-16, under 510(k) number K970751.

Who is the listed applicant for HEIDELBERG EXTERNAL FIXATOR?

The FDA 510(k) record lists Smith & Nephew, Inc., Orthopaedic Div. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEIDELBERG EXTERNAL FIXATOR?

The FDA product code for HEIDELBERG EXTERNAL FIXATOR is JDW.

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Other records listing Smith & Nephew, Inc., Orthopaedic Div. 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.

K991538OPERA CUPFLANGED ACETABULAR COMPONENTSK970635TITANIUM SPINAL ROD SYSTEMK971414ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADSK970748TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEMK970713COMPASS UNIVERSAL HINGEK970337HA GLOBAL TAPER (GT) TAPERED HIP STEM

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Related Devices (Code: JDW)

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.

K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLCK241357XT3 SystemBiodynamik, Inc.K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc.K213874MAVERICK External Fixation SystemSmith & Nephew, Inc.K211508Steinmann Pins and Kirschner WiresStryker GmbH

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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