FDA.reportPublic FDA data

Anchor Threaded Titanium-PEEK

Primary DI
06009712642816
Brand
Anchor Threaded Titanium-PEEK
Company
ORTHO-DESIGN (PTY) LTD
Model
ATX-6.5x17 2T
Catalog number
ATX-6.5x17 2T
Device description
Threaded Ti-PEEK 6.5x17mm 2 Tape
Published
2023-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K212381000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212381000VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.2021-12-06MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009712642816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009712642816060097126428166009712642816

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)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter6.5Millimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+27128075172dianpeach@ortho-design.co.za

Regulatory Flags#

DUNS number
557386523
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
true
Expiration date on label
true
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
06009712642236VersaPEEKAPP001APP0012025-08-11
06009712642243VersaPEEKAPP002APP0022025-08-11
06009712642267VersaPEEKAPP002-NAPP002-N2025-08-11
06009712642861VersaTap /VersaLat RecoveryADP003-2ADP003-22024-06-24
06009712642878VersaTap Tip RecoveryADP004-2ADP004-22024-06-24
06009712642885DoubleTapADP009-2ADP009-22024-06-24
06009712642892VersaPEEK Tapping ToolAPP001-2APP001-22024-06-24
06009712642731Anchor Threaded TitaniumATT-2x6 2S NDATT-2x6 2S ND2023-12-07
06009712642748Anchor Threaded TitaniumATT-3x11 2S NATT-3x11 2S N2023-12-07
06009712642755Anchor Threaded TitaniumATT-4x13 2S NATT-4x13 2S N2023-12-07
06009712642762Anchor Threaded TitaniumATT-6x17 2S NATT-6x17 2S N2023-12-07
06009712642779Anchor Impact PEEKABP-2.9x10 S NABP-2.9x10 S N2023-12-07
06009712642786Anchor Threaded PEEKATP-5.5x15 2S NATP-5.5x15 2S N2023-12-07
06009712642793Anchor Threaded Titanium-PEEKATX-6.5x17 2SATX-6.5x17 2S2023-12-07
06009712642809Anchor Threaded Titanium-PEEKATX-6.5x17 STATX-6.5x17 ST2023-12-07
06009712642823Anchor Threaded Titanium-PEEKATX-6.5x17 2S NATX-6.5x17 2S N2023-12-07
06009712642656VersaTi 3mm DrillATP004-01ATP004-012023-10-05
06009712642403DueLock 2.9mm DrillADP013ADP0132023-09-07
06009712642434VersaTap/Lat Removal ToolADP003-1ADP003-12023-09-07
06009712642441VersaTap Tip RemovalADP004-1ADP004-12023-09-07

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