FDA.reportPublic FDA data

Reform TI

Primary DI
00840019934367
Brand
Reform TI
Company
PRECISION SPINE, INC.
Model
39-TC-6540
Catalog number
39-TC-6540
Device description
Ø6.5 x 40mm Polyaxial Screw, Cannulated
Published
2019-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200303000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200303000Reform Pedicle Screw SystemPrecision Spine2020-05-19NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840019934367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019934367008400199343678400199343670840019934367

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation implant/sterilization container setA collection of non-sterile, implantable components of an internal spinal fixation assembly (e.g., plates, rods, screws, connectors, and/or hooks) packaged within a reusable sterilization container (i.e., all under the same product code) to be sterilized prior to implantation. The set provides the surgeon with a selection of implants (e.g., different sizes) during surgery, whereby unused implants may be resterilised for subsequent implantation in another patient. Instruments intended to facilitate implantation may be packaged with the set. This is a reusable device which includes single-use implants.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079398589
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840019972895Navigated Instrument System70-SP-260070-SP-26002025-03-07
00840019973045Reform Ti Modular73-BK-010273-BK-01022025-03-05
00840019973069Reform Ti Modular73-BK-010473-BK-01042025-03-05
00840019972918Reform Ti Modular73-SP-260073-SP-26002025-01-24
00840019934800Reform Ti39-TC-109039-TC-10902019-10-04
00840019934817Reform Ti39-TC-100039-TC-10002019-10-04
00840019934824Reform Ti39-TC-101139-TC-10112019-10-04
00840019934831Reform Ti39-TC-101239-TC-10122019-10-04
00840019935319Reform Ti39-TD-951239-TD-95122019-10-07
00840019935364Reform Ti39-TD-106039-TD-10602019-10-07
00840019934725Reform Ti39-TC-951239-TC-95122019-09-25
00840019934732Reform Ti39-TC-104039-TC-10402019-09-25
00840019934749Reform Ti39-TC-104539-TC-10452019-09-25
00840019934756Reform Ti39-TC-105039-TC-10502019-09-25
00840019934763Reform Ti39-TC-105539-TC-10552019-09-25
00840019934770Reform Ti39-TC-106039-TC-10602019-09-25
00840019934787Reform Ti39-TC-107039-TC-10702019-09-25
00840019934794Reform Ti39-TC-108039-TC-10802019-09-25
00840019934251Reform Ti39-TC-552539-TC-55252019-09-10
00840019934268Reform Ti39-TC-553039-TC-55302019-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157082130ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082147ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082154ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082161ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082178ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082185ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082192ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082208ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082215ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082222ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082239ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082246ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082253ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082260ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082277ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082284ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082291ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082307ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082314ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082321ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082338ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082345ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082352ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082369ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082376ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082383ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082390ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082406ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082413ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082420ZAVATION SCREWZavation LLCKWP2026-07-23