Agee TurnKey FCS®

GUDID 00861994000229

External fixation system for acute dorsal fracture dislocations of the PIP joint.

Hand Biomechanics Lab Inc

Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable
Primary Device ID00861994000229
NIH Device Record Keye803dfba-7b36-4f78-8a55-890f3e1e402b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAgee TurnKey FCS®
Version Model NumberFCS-400
Company DUNS620754127
Company NameHand Biomechanics Lab Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100861994000229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JECComponent, Traction, Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-23

Devices Manufactured by Hand Biomechanics Lab Inc

00861994000281 - Disposable Blade Assembly2021-12-14 Endoscopic Carpal Tunnel Release Disposable Blade Assembly
00861994000243 - PIP Fix2019-03-11 External fixation system for dorsal fracture dislocations of the PIP joint.
00861994000205 - Agee WristJack®2018-07-06 Fracture Reduction System. Fracture reduction and external fixation for treatment of distal radius fractures.
00861994000212 - Agee Digit Widget®2018-07-06 External fixation system for treatment of PIP joint flexion contractures.
00861994000229 - Agee TurnKey FCS®2018-07-06External fixation system for acute dorsal fracture dislocations of the PIP joint.
00861994000229 - Agee TurnKey FCS®2018-07-06 External fixation system for acute dorsal fracture dislocations of the PIP joint.
00861994000236 - Agee WristJack® Remanufactured2018-07-06 Fracture reduction system, remanufactured version. Fracture reduction and external fixation for treatment of distal radius fract
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