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FDA 510(k)

POWERGRIP(TM) COMPRESSION FIXATION DEVICE

K-Number: K950009 · 1995-08-18

ApplicantSynvasive Technology, Inc.
Decision Date1995-08-18
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POWERGRIP(TM) COMPRESSION FIXATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Synvasive Technology, Inc.. It received FDA 510(k) clearance on 1995-08-18 under 510(k) number K950009. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWERGRIP(TM) COMPRESSION FIXATION DEVICE?

POWERGRIP(TM) COMPRESSION FIXATION DEVICE is a medical device that received FDA 510(k) clearance on 1995-08-18. The listed applicant is Synvasive Technology, Inc.. The 510(k) number is K950009.

When did POWERGRIP(TM) COMPRESSION FIXATION DEVICE receive FDA 510(k) clearance?

POWERGRIP(TM) COMPRESSION FIXATION DEVICE received FDA 510(k) clearance on 1995-08-18, under 510(k) number K950009.

Who is the listed applicant for POWERGRIP(TM) COMPRESSION FIXATION DEVICE?

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

What is the FDA product code for POWERGRIP(TM) COMPRESSION FIXATION DEVICE?

The FDA product code for POWERGRIP(TM) COMPRESSION FIXATION DEVICE is JDW.

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Other records listing Synvasive Technology, 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.

K093046ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZESK070108ELIBRA DYNAMIC KNEE BALANCERK972508SURGICAL BURS AND SURGICAL DRILL BITSK961522KIRSCHNER WIRE (K-WIRE) AND STEINMANN PINK934336SPINALPLANEK933933CEBOPLANE

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Related Devices (Code: JDW)

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.

K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLCK241357XT3 SystemBiodynamik, Inc.K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc.K213874MAVERICK External Fixation SystemSmith & Nephew, Inc.K211508Steinmann Pins and Kirschner WiresStryker 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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