FDA.report

Easyspine

Primary DI
03662663004602
Brand
Easyspine
Company
LDR Spine Usa, Inc.
Model
ES865T
Device description
STANDARD LP PEDICLE SCREW D6 L55mm
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Product Code Classifications

CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03662663004602PrimaryGS10

GMDN Terms

TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

Device Sizes

TypeValueUnit
Length55Millimeter
Outer Diameter6Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
512-344-3333surgeoninfo@ldrspine.com

Regulatory Flags

DUNS number
615789729
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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03662663059183Mobi-C Plug & Fit USMB9176R2024-01-15
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03662663000222Mobi-CMB903RMB903R2018-12-13
03662663000239Mobi-CMB904RMB904R2018-12-12
03662663000246Mobi-CMB906RMB906R2018-12-12
03662663000369Mobi-CMB942RMB942R2018-12-12
03662663000376Mobi-CMB943RMB943R2018-12-13
03662663000383Mobi-CMB944RMB944R2018-12-13
03662663000390Mobi-CMB945RMB945R2018-12-13
03662663000406Mobi-CMB946RMB946R2018-12-13
03662663000413Mobi-CMB947RMB947R2018-12-13
03662663000420Mobi-CMB948RMB948R2018-12-13
03662663000437Mobi-CMB949RMB949R2018-12-13
03662663000819Mobi-C® Plug & Fit USMB9008R2014-09-24
03662663000826Mobi-C® Plug & Fit USMB9009R2014-09-24
03662663000833Mobi-C® Plug & Fit USMB9010R2014-09-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840493418704RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418711RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418728RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418735RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418742RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418759RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418766RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418773RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418780RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418797RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418803RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418810RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418827RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418834RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418841RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418858RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418865RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418872RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418889RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418896RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418902RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418919RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418926RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418933RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418940RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418957RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418964RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418971RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00190837124458ArxLife Spine, Inc.NKB2026-03-23
00190837124465ArxLife Spine, Inc.NKB2026-03-23