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FDA 510(k)

UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY

K-Number: K872715 · 1987-12-07

ApplicantRoseburg SA
Decision Date1987-12-07
Product CodeJDN
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY is the device name listed in this FDA 510(k) record. The listed applicant is Roseburg SA. It received FDA 510(k) clearance on 1987-12-07 under 510(k) number K872715. 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 UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY?

UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY is a medical device that received FDA 510(k) clearance on 1987-12-07. The listed applicant is Roseburg SA. The 510(k) number is K872715.

When did UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY receive FDA 510(k) clearance?

UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY received FDA 510(k) clearance on 1987-12-07, under 510(k) number K872715.

Who is the listed applicant for UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY?

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

What is the FDA product code for UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY?

The FDA product code for UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY is JDN.

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Other records listing Roseburg SA 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.

K931155STAPLE, FIXATION BONE; SCREW FIXATION BONEK890081CALIUS-ISABEL CANOVAS SUNGLASSESK885275ASSENAT-BLESCHET SUNGLASSESK882392BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVESK874317POIRIER KID-ROLLER MANUAL WHEELCHAIRK872714S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY

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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 GmbHK873977NEW C-D SYSTEM FOR SPINAL SURGERYSofamor Co.K760649TOTAL 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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