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FDA 510(k)

MOSS 100 Pedicle Screw System

K-Number: K162232 · 2016-11-17

ApplicantBiedermann Motech GmbH & Co. KG
Decision Date2016-11-17
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MOSS 100 Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Biedermann Motech GmbH & Co. KG. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K162232. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOSS 100 Pedicle Screw System?

MOSS 100 Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Biedermann Motech GmbH & Co. KG. The 510(k) number is K162232.

When did MOSS 100 Pedicle Screw System receive FDA 510(k) clearance?

MOSS 100 Pedicle Screw System received FDA 510(k) clearance on 2016-11-17, under 510(k) number K162232.

Who is the listed applicant for MOSS 100 Pedicle Screw System?

The FDA 510(k) record lists Biedermann Motech GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOSS 100 Pedicle Screw System?

The FDA product code for MOSS 100 Pedicle Screw System is NKB.

Other records listing Biedermann Motech GmbH & Co. KG 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.

K203607MOSS VRS Spinal SystemK181821MOSS VRS Spinal SystemK170890TELIX K Interbody System

Related Devices (Code: NKB)

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.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

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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