FDA.reportPublic FDA data

OP Response Spine System

Primary DI
00841132120477
Brand
OP Response Spine System
Company
ORTHOPEDIATRICS CORP.
Model
00-1003-4069
Catalog number
00-1003-4069
Device description
POLYAXIAL SCREW 4.0MM X 35MM
Published
2015-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
OSHPedicle screw spinal system, adolescent idiopathic scoliosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130655000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130655000RESPONSE SPINE SYSTEMOrthoPediatrics Corp.2013-05-08OSH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841132120477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132120477008411321204778411321204770841132120477

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(574)268-6379Rbremer@orthopediatrics.com

Regulatory Flags#

DUNS number
796416191
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840194405980Pediatric Nailing Platform Femur01-1501-052001-1501-05202022-09-16
00840194405997Pediatric Nailing Platform Femur01-1503-005501-1503-00552022-09-16
00840194406000Pediatric Nailing Platform Femur01-1503-005601-1503-00562022-09-16
00840194407687Pediatric Nailing Platform Femur01-1501-010201-1501-01022022-09-16
00840194407700Pediatric Nailing Platform Femur01-1503-005701-1503-00572022-09-16
00840194407717Pediatric Nailing Platform Femur01-1503-005801-1503-00582022-09-16
00840194407724Pediatric Nailing Platform Femur01-1503-005901-1503-00592022-09-16
00840194407748Pediatric Nailing Platform Femur01-1501-052101-1501-05212022-09-16
00840194417280Pediatric Nailing Platform Femur01-1501-015001-1501-01502022-09-16
00840194417297Pediatric Nailing Platform Femur01-1501-015101-1501-01512022-09-16
00840194417303Pediatric Nailing Platform Femur01-1501-015201-1501-01522022-09-16
00840194417310Pediatric Nailing Platform Femur01-1501-052201-1501-05222022-09-16
00840194417327Pediatric Nailing Platform Femur01-1501-052301-1501-05232022-09-16
00840194417334Pediatric Nailing Platform Femur01-1501-052401-1501-05242022-09-16
00840194445986Pediatric Nailing Platform | Tibia01-1510-005001-1510-00502023-09-15
00840194445993Pediatric Nailing Platform | Tibia01-1510-005101-1510-00512023-09-15
00840194462587Pediatric Nailing Platform | Tibia01-1540-000001-1540-00002023-09-15
00840194462594Pediatric Nailing Platform | Tibia01-1540-000101-1540-00012023-09-15
00840194462686Pediatric Nailing Platform | Tibia01-1510-006001-1510-00602023-09-15
00840194462693Pediatric Nailing Platform | Tibia01-1510-006101-1510-00612023-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840019978484Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978491Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978507Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978514Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978521Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978538Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978545Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978552Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978569Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978576Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978583Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978590Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978606Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978613Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978620Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978637Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978644Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978651Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978668Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978675Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978682Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978699Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978705Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978712Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978729Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978736Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978743Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978750Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978767Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978774Reform TiPRECISION SPINE, INC.KWP2026-11-05