FDA.reportPublic FDA data

Specials

Primary DI
10889981291303
Brand
Specials
Company
Seaspine Orthopedics Corporation
Model
SR-0789
Catalog number
SR-0789
Device description
Admiral ACP Angled DTS Guide
Published
2022-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, fixation, spinal intervertebral body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202064000Admiral ACP SystemSeaSpine Orthopedics Corporation2020-08-26KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981291303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998129130310889981291303

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

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
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
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.KWQ2026-09-22
10888857598164Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
00810056993146corraCarlsmed, Inc.KWQ2026-01-30
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2015-08-05
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04546540147905XIA IIStryker CorporationKWQ2014-12-08
04546540147912XIA IStryker CorporationKWQ2014-12-08
04546540147929XIA IStryker CorporationKWQ2014-12-08
04546540147936XIA IStryker CorporationKWQ2014-12-08
04546540147974XIA IStryker CorporationKWQ2014-12-08
04546540147981XIA IStryker CorporationKWQ2014-12-08
04546540147998XIA IStryker CorporationKWQ2014-12-08
04546540148001XIA IIStryker CorporationKWQ2014-12-08
04546540148018XIA IIStryker CorporationKWQ2014-12-08
04546540148025XIA IIStryker CorporationKWQ2014-12-08