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FDA 510(k)

S-COMP Reform® POCT Navigation Instruments

K-Number: K231229 · 2023-05-25

ApplicantPrecision Spine, Inc.
Decision Date2023-05-25
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

S-COMP Reform® POCT Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Precision Spine, Inc.. It received FDA 510(k) clearance on 2023-05-25 under 510(k) number K231229. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-COMP Reform® POCT Navigation Instruments?

S-COMP Reform® POCT Navigation Instruments is a medical device that received FDA 510(k) clearance on 2023-05-25. The listed applicant is Precision Spine, Inc.. The 510(k) number is K231229.

When did S-COMP Reform® POCT Navigation Instruments receive FDA 510(k) clearance?

S-COMP Reform® POCT Navigation Instruments received FDA 510(k) clearance on 2023-05-25, under 510(k) number K231229.

Who is the listed applicant for S-COMP Reform® POCT Navigation Instruments?

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

What is the FDA product code for S-COMP Reform® POCT Navigation Instruments?

The FDA product code for S-COMP Reform® POCT Navigation Instruments is OLO.

Other records listing Precision Spine, Inc. as applicant

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Related Devices (Code: OLO)

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.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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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