FDA.reportPublic FDA data

SPINAL BALANCE, INC.

Matched from indexed company URL: Spinal Balance, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30117098333011709833SPINAL BALANCE, INC.1N2020-04-2511360 S Airfield Road Swanton OH US 43558

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00841327102745Libra Pedicle Screw System - Libra Screw Assembly, Polyaxial, 4.5mm x 25mm419-530-5940customerservice@spinalbalance.us
00841327102752Libra Pedicle Screw System - Libra Screw Assembly, Polyaxial, 4.5mm x 30mm419-530-5940customerservice@spinalbalance.us
00841327102769Libra Pedicle Screw System - Libra Screw Assembly, Polyaxial, 4.5mm x 35mm419-530-5940customerservice@spinalbalance.us
00841327102776Libra Pedicle Screw System - Libra Screw Assembly, Polyaxial, 4.5mm x 40mm419-530-5940customerservice@spinalbalance.us
00841327102783Libra Pedicle Screw System - Libra Screw Assembly, Polyaxial, 4.5mm x 45mm419-530-5940customerservice@spinalbalance.us
00841327102790Libra Pedicle Screw System - Libra Screw Assembly, Polyaxial, 4.5mm x 50mm419-530-5940customerservice@spinalbalance.us

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1919111280769816K162750Libra Pedicle Screw SystemNKB2016-10-27
1919111447873487K151770Libra Pedicle Screw SystemNKB2015-11-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB22016-10-27

PMN#

GUDID#

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