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FDA 510(k)

TEXAS SCOTTISH RITE EASY/LOCK FIXATOR

K-Number: K931578 · 1994-02-22

ApplicantApplied Osteo Systems, Inc.
Decision Date1994-02-22
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TEXAS SCOTTISH RITE EASY/LOCK FIXATOR is the device name listed in this FDA 510(k) record. The listed applicant is Applied Osteo Systems, Inc.. It received FDA 510(k) clearance on 1994-02-22 under 510(k) number K931578. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEXAS SCOTTISH RITE EASY/LOCK FIXATOR?

TEXAS SCOTTISH RITE EASY/LOCK FIXATOR is a medical device that received FDA 510(k) clearance on 1994-02-22. The listed applicant is Applied Osteo Systems, Inc.. The 510(k) number is K931578.

When did TEXAS SCOTTISH RITE EASY/LOCK FIXATOR receive FDA 510(k) clearance?

TEXAS SCOTTISH RITE EASY/LOCK FIXATOR received FDA 510(k) clearance on 1994-02-22, under 510(k) number K931578.

Who is the listed applicant for TEXAS SCOTTISH RITE EASY/LOCK FIXATOR?

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

What is the FDA product code for TEXAS SCOTTISH RITE EASY/LOCK FIXATOR?

The FDA product code for TEXAS SCOTTISH RITE EASY/LOCK FIXATOR is JEC.

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Other records listing Applied Osteo Systems, 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.

K935383FEMROD AND FEMROD RECON INSERTK933995TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATIONK944501TRUE/FLEX INTRAMEDULLARY ROD END-CAPK941048TRUE/LOK MONOLATERAL/BILATERAL FIXATORK943160INTERFERENCE SCREWK934148TRUE/FLEX CLAVICLE RODS

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Related Devices (Code: JEC)

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.

K203605SteriTrakArbutus Medical, Inc.K193256Anjon Bremer Halo SystemAnjon Holdings, LLCK192465DigiFix Sterile KitVirak Orthopedics, LLCK181192PIP FixHand Biomechanics Lab, Inc.K171863Anjon Bremer Halo SystemAnjon Holdings, LLCK163028Medline ReNewal Reprocessed Stryker External Fixation DevicesSurgical Instrument Service and Savings, 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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