FDA.reportPublic FDA data

Reform Pedicle Screw System

Primary DI
00840019902045
Brand
Reform Pedicle Screw System
Company
PRECISION SPINE, INC.
Model
39-TH-0351
Catalog number
39-TH-0351
Device description
Off. Ang. Red. Hook, MD, Right
Published
2019-05-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130279000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130279000REFORM PEDICLE SCREW SYSTEMSpinal USA2013-06-20MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840019902045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019902045008400199020458400199020450840019902045

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-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. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079398589
Device count
1
DM exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840019970907MD-Vue™ Lateral Access System54-TA-050054-TA-05002026-05-01
00840019970914MD-Vue™ Lateral Access System54-TA-060054-TA-06002026-05-01
00840019970921MD-Vue™ Lateral Access System54-TA-070054-TA-07002026-05-01
00840019970938MD-Vue™ Lateral Access System54-TA-080054-TA-08002026-05-01
00840019970945MD-Vue™ Lateral Access System54-TA-090054-TA-09002026-05-01
00840019970952MD-Vue™ Lateral Access System54-TA-100054-TA-10002026-05-01
00840019971133Reform Ti Modular39-SF-654539-SF-65452026-01-13
00840019971140Reform Ti Modular39-SF-655039-SF-65502026-01-13
00840019971157Reform Ti Modular39-SF-655539-SF-65552026-01-13
00840019971164Reform Ti Modular39-SF-656039-SF-65602026-01-13
00840019971171Reform Ti Modular39-SF-753039-SF-75302026-01-13
00840019971188Reform Ti Modular39-SF-753539-SF-75352026-01-13
00840019971195Reform Ti Modular39-SF-754039-SF-75402026-01-13
00840019971201Reform Ti Modular39-SF-754539-SF-75452026-01-13
00840019971218Reform Ti Modular39-SF-755039-SF-75502026-01-13
00840019971225Reform Ti Modular39-SF-755539-SF-75552026-01-13
00840019971232Reform Ti Modular39-SF-756039-SF-75602026-01-13
00840019971249Reform Ti Modular39-SF-757039-SF-75702026-01-13
00840019971256Reform Ti Modular39-SF-758039-SF-75802026-01-13
00840019971263Reform Ti Modular39-SF-853539-SF-85352026-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700780634583Erisma®-LPCLARIANCEMNH2026-05-28
03700780634583Erisma®-LPCLARIANCEMNI2026-05-28
04052536085491neon3Ulrich GmbH & Co. KGKWP2026-05-28
07613153143734XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153143734XIA STAINLESS STEELStryker CorporationKWP2015-09-14
07613153143734XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143741XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143741XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153143741XIA STAINLESS STEELStryker CorporationKWP2015-09-14
07613153143758XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143758XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153143765XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143765XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153045670XIA IStryker CorporationMNH2014-12-08
07613153045670XIA IStryker CorporationKWP2014-12-08
07613153045700XIA IStryker CorporationKWP2014-12-08
07613153045700XIA IStryker CorporationMNI2014-12-08
07613153045700XIA IStryker CorporationMNH2014-12-08
07613153045717XIA IStryker CorporationKWP2014-12-08
07613153045717XIA IStryker CorporationMNH2014-12-08
07613153045717XIA IStryker CorporationMNI2014-12-08
07613153045724XIA IStryker CorporationMNI2014-12-08
07613153045724XIA IStryker CorporationKWP2014-12-08
07613153045731XIA IStryker CorporationMNI2014-12-08
07613153045731XIA IStryker CorporationMNH2014-12-08
07613153045731XIA IStryker CorporationKWP2014-12-08
07613153045748XIA IStryker CorporationMNH2014-12-08
07613153045748XIA IStryker CorporationMNI2014-12-08
07613153045755XIA IStryker CorporationMNH2014-12-08
07613153045755XIA IStryker CorporationKWP2014-12-08