FDA.reportPublic FDA data

Reform HA Coated Pedicle Screw System

Primary DI
00815362020197
Brand
Reform HA Coated Pedicle Screw System
Company
PRECISION SPINE, INC.
Model
39-PH-6555
Catalog number
39-PH-6555
Device description
6.5 x 55mm Reform HA Coated Pedicle Screw System
Published
2019-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBThoracolumbosacral Pedicle Screw System
OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151422000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151422000Reform Pedicle Screw SystemPrecision Spine, Inc.2015-08-21NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815362020197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815362020197008153620201978153620201970815362020197

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079398589
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
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
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