FDA.reportPublic FDA data

Sierra™

Primary DI
10889981043964
Brand
Sierra™
Company
Seaspine Orthopedics Corporation
Model
51-4532
Catalog number
51-4532
Device description
Sierra Extended Tab Screw, 04.5 x 32mm
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062934000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062934000SIERRASeaspine, Inc.2006-11-16MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981043964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998104396410889981043964

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, single-use, sterileA sterile metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)942-8698custsvcspine@seaspine.com

Regulatory Flags#

DUNS number
079840876
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889981172374Mariner Outrigger99-000899-00082019-07-26
10889981172466Mariner Outrigger99-001799-00172019-07-26
10889981172695Mariner Outrigger99-1010-1299-1010-122019-07-30
10889981172732Mariner Outrigger99-1012-1299-1012-122019-07-30
10889981172749Mariner Outrigger99-1012-1499-1012-142019-07-30
10889981172800Mariner Outrigger99-1015-1499-1015-142019-07-30
10889981184940Mariner Outrigger99-1023-1299-1023-122019-07-30
10889981125783Newport MIS64-856564-85652025-12-19
10889981125790Newport MIS64-857064-85702025-12-19
10889981125837NewPort64-957064-95702024-12-11
10889981125844NewPort64-958064-95802024-12-11
10889981130060NewPort64-555064-55502024-12-11
10889981130077NewPort64-657564-65752024-12-11
10889981130091NewPort64-853064-85302024-12-11
10889981134921NewPort64-472564-47252024-12-11
10889981134938NewPort64-476064-47602024-12-11
10889981134945NewPort64-475564-47552024-12-11
10889981135348NewPort64-553064-55302024-12-11
10889981135355NewPort64-553564-55352024-12-11
10889981135362NewPort64-554064-55402024-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-06-28
00643169101296MSB VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-27
10889981441555VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981065348MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065539MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065553MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065577MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065584MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065607MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065645MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065669MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065683MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065706MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065720MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065744MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065768MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065782MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065805MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065829MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065843MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065867MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065881MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065904MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065928MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065959MarinerSeaspine Orthopedics CorporationMNI2016-09-02