FDA.reportPublic FDA data

Reform Ti

Primary DI
00840019978613
Brand
Reform Ti
Company
PRECISION SPINE, INC.
Model
39-RM-6555
Catalog number
39-RM-6555
Device description
ø6.5mm x 55mm Reduction Uniplanar Screw
Published
2026-11-05
Public version status
New
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
00840019978613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019978613008400199786138400199786130840019978613

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
00840019978484Reform Ti39-RM-553039-RM-55302026-11-05
00840019978491Reform Ti39-RM-553539-RM-55352026-11-05
00840019978507Reform Ti39-RM-554039-RM-55402026-11-05
00840019978514Reform Ti39-RM-554539-RM-55452026-11-05
00840019978521Reform Ti39-RM-555039-RM-55502026-11-05
00840019978538Reform Ti39-RM-555539-RM-55552026-11-05
00840019978545Reform Ti39-RM-556039-RM-55602026-11-05
00840019978552Reform Ti39-RM-652539-RM-65252026-11-05
00840019978569Reform Ti39-RM-653039-RM-65302026-11-05
00840019978576Reform Ti39-RM-653539-RM-65352026-11-05
00840019978583Reform Ti39-RM-654039-RM-65402026-11-05
00840019978590Reform Ti39-RM-654539-RM-65452026-11-05
00840019978606Reform Ti39-RM-655039-RM-65502026-11-05
00840019978620Reform Ti39-RM-656039-RM-65602026-11-05
00840019978637Reform Ti39-RM-753039-RM-75302026-11-05
00840019978644Reform Ti39-RM-753539-RM-75352026-11-05
00840019978651Reform Ti39-RM-754039-RM-75402026-11-05
00840019978668Reform Ti39-RM-754539-RM-75452026-11-05
00840019978675Reform Ti39-RM-755039-RM-75502026-11-05
00840019978682Reform Ti39-RM-755539-RM-75552026-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157125325ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125332ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125349ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125356ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125363ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125370ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125387ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125394ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125400ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125417ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125424ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125448ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125455ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125462ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125479ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125486ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125493ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125509ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125516ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125523ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125530ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125547ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125554ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125561ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125578ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125585ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125592ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125608ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125615ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125622ZAVATION SCREWZavation LLCNKB2026-11-05