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FDA 510(k)

SUPERFIXATION(TM)

K-Number: K863343 · 1986-09-15

ApplicantOrthopaedic Device Corp.
Decision Date1986-09-15
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SUPERFIXATION(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Orthopaedic Device Corp.. It received FDA 510(k) clearance on 1986-09-15 under 510(k) number K863343. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPERFIXATION(TM)?

SUPERFIXATION(TM) is a medical device that received FDA 510(k) clearance on 1986-09-15. The listed applicant is Orthopaedic Device Corp.. The 510(k) number is K863343.

When did SUPERFIXATION(TM) receive FDA 510(k) clearance?

SUPERFIXATION(TM) received FDA 510(k) clearance on 1986-09-15, under 510(k) number K863343.

Who is the listed applicant for SUPERFIXATION(TM)?

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

What is the FDA product code for SUPERFIXATION(TM)?

The FDA product code for SUPERFIXATION(TM) is KTT.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Orthopaedic Device 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.

K870234P.T.H. METAL-BACKED ACETABULAR CUPK862460FEMORAL HEMI-HIP PROSTHESISK855228FEMORAL HEMI-HIP PROSTHESES

Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker 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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