FDA.reportPublic FDA data

ANCHORMAN

Primary DI
15060238200971
Brand
ANCHORMAN
Company
SUMMIT MEDICAL LIMITED
Model
D201019
Device description
ANCHORMAN is a cortical tibial ligament fixation device. It consists of a sterile, double pouched Polyether ether ketone (PEEK) loop with two petals which rest on the cortical bone of the tibia
Published
2018-12-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170388000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170388000ANCHORMAN Tibial Ligament Fixation DeviceSummit Medical , Ltd.2017-07-25MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060238200971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506023820097115060238200971

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in the original packaging away from direct sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441451821311info@summit-medical.co.uk

Regulatory Flags#

DUNS number
221751311
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060238201923Vacuum Cement Mixing Bowl1400-21001400-21002025-11-18
25060238201920Vacuum Cement Mixing Bowl1400-21001400-21002025-11-18
15060238201138CellTrans ABT45102018-12-21
15060238201329Spatula & Curette PackSC012022-08-23
15060238201596Femoral Cement PressuriserP721P7212025-01-10
15060238201633HiVac™ 7 Triple Mix C703C7032025-01-10
15060238201657HiVac™ 7 with Femoral Cement Pressuriser CP701CP7012025-01-10
15060238201671HiVac™ SyringeS727S7272025-01-10
15060238201688HiVac™ SyringeS717WS717W2025-01-10
150602382017189mm Nozzle With Nozzle ExtruderN700N7002025-01-10
15060238201725Quick-Vac® Vacuum Mixing Bowl00504900100005049001002025-01-10
15060238201732Quick-Vac® Vacuum Mixing Bowl00504900115005049001152025-01-10
15060238201749HiVac BowlB713B7132025-01-10
15060238201756Rally™ Vacuum Mixing Bowl7127-18017127-18012025-01-10
15060238201770Cement Mixing and Delivery System00-4501-090-0000-4501-090-002025-01-10
15060238201787 MiniMix™SMMM1SMMM12025-01-10
15060238201794MiniMix™ LVSMLVSMLV2025-01-10
15060238201800MiniMix™ Delivery SyringeSMDS1CSMDS1C2025-01-10
15060238201886Mixing bowl, SpatulaB710B7102025-01-10
25060238201593Femoral Cement PressuriserP721P7212025-01-10

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00810198920178TeKBraceTheraMicro, LLCMBI2026-08-14
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10810128462881VersiTILT Drill Pin, 3.1mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
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