FDA.reportPublic FDA data

Daytona® Small Stature

Primary DI
10889981186760
Brand
Daytona® Small Stature
Company
Seaspine Orthopedics Corporation
Model
77-7545-SPN
Catalog number
77-7545-SPN
Device description
Cann Uni-Planar Screw, 7.5 x 45mm, Sm Stat
Published
2020-08-12
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWQAppliance, fixation, spinal intervertebral body
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981186760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998118676010889981186760

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(760)727-8399custsvcspine@seaspine.com

Regulatory Flags#

DUNS number
079840876
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
10889981186753Daytona® Small Stature77-7540-SPN77-7540-SPN2020-08-12
10889981186777Daytona® Small Stature77-7550-SPN77-7550-SPN2020-08-12
10889981442187REEF LRL2-100608RL2-1006082026-06-19
10889981443344REEF LRL3-109002RL3-1090022026-06-19
10889981326234RegattaRP1-200200RP1-2002002025-01-17
10889981326777RegattaRP1-000308RP1-0003082025-01-17
10889981326784RegattaRP1-000310RP1-0003102025-01-17
10889981326791RegattaRP1-000312RP1-0003122025-01-17
10889981326807RegattaRP1-000314RP1-0003142025-01-17
10889981326814RegattaRP1-000316RP1-0003162025-01-17
10889981326821RegattaRP1-000318RP1-0003182025-01-17
10889981326838RegattaRP1-000320RP1-0003202025-01-17
10889981329969RegattaRP3-209300RP3-2093002025-01-17
10889981330002WaveForm LWL4-184015WL4-1840152025-01-17
10889981330026WaveForm LWL4-184515WL4-1845152025-01-17
10889981330040WaveForm LWL4-185015WL4-1850152025-01-17
10889981330064WaveForm LWL4-185515WL4-1855152025-01-17
10889981330088WaveForm LWL4-186015WL4-1860152025-01-17
10889981330101WaveForm LWL4-284015WL4-2840152025-01-17
10889981330125WaveForm LWL4-284515WL4-2845152025-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157123673ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123680ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123697ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123703ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123710ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123727ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123734ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123741ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123758ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123765ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123772ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123789ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123796ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123802ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123819ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123826ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123833ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123840ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123857ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123864ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123871ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123888ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123895ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123901ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123918ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123925ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123932ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123949ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123956ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123963ZAVATION SCREWZavation LLCNKB2026-11-02