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FDA 510(k)

NEW C-D SYSTEM FOR SPINAL SURGERY

K-Number: K873977 · 1987-12-07

ApplicantSofamor Co.
Decision Date1987-12-07
Product CodeJDN
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

NEW C-D SYSTEM FOR SPINAL SURGERY is the device name listed in this FDA 510(k) record. The listed applicant is Sofamor Co.. It received FDA 510(k) clearance on 1987-12-07 under 510(k) number K873977. The device is classified under product code JDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the NEW C-D SYSTEM FOR SPINAL SURGERY?

NEW C-D SYSTEM FOR SPINAL SURGERY is a medical device that received FDA 510(k) clearance on 1987-12-07. The listed applicant is Sofamor Co.. The 510(k) number is K873977.

When did NEW C-D SYSTEM FOR SPINAL SURGERY receive FDA 510(k) clearance?

NEW C-D SYSTEM FOR SPINAL SURGERY received FDA 510(k) clearance on 1987-12-07, under 510(k) number K873977.

Who is the listed applicant for NEW C-D SYSTEM FOR SPINAL SURGERY?

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

What is the FDA product code for NEW C-D SYSTEM FOR SPINAL SURGERY?

The FDA product code for NEW C-D SYSTEM FOR SPINAL SURGERY is JDN.

Related Clinical Trials

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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Other records listing Sofamor Co. 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.

K940744SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATIONK945022APOFIX CERVICAL SPINE FIXATIONK934007SOFAMOR ORFIL SPINE FIXATION SYSTEMK843687ROD FOR RACHIS SURGERY

Related Devices (Code: JDN)

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.

K954856CANNULATED FEMORAL NAILSynthes (Usa)K897141SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIOStuartK894184BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEMBiedermann Motech GmbHK872715UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERYRoseburg SAK760649TOTAL SPINAL CORRECTIONDepuy, 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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