Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Stryker 90-S Max SERFAS Energy Probe

K-Number: K171391 · 2018-01-26

ApplicantStryker
Decision Date2018-01-26
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Stryker 90-S Max SERFAS Energy Probe is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2018-01-26 under 510(k) number K171391. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stryker 90-S Max SERFAS Energy Probe?

Stryker 90-S Max SERFAS Energy Probe is a medical device that received FDA 510(k) clearance on 2018-01-26. The listed applicant is Stryker. The 510(k) number is K171391.

When did Stryker 90-S Max SERFAS Energy Probe receive FDA 510(k) clearance?

Stryker 90-S Max SERFAS Energy Probe received FDA 510(k) clearance on 2018-01-26, under 510(k) number K171391.

Who is the listed applicant for Stryker 90-S Max SERFAS Energy Probe?

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

What is the FDA product code for Stryker 90-S Max SERFAS Energy Probe?

The FDA product code for Stryker 90-S Max SERFAS Energy Probe is GEI.

Other records listing Stryker 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.

K261481Pangea Femur Reconstruction SystemK253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemK253202Hoffmann LRF SystemK251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemK250163T2 Alpha Femur Retrograde Nailing SystemK242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System

View all 164 devices →

Related Devices (Code: GEI)

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.

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbHK253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology CorporationK251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

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.

↑