FDA.reportPublic FDA data

VersaTap /VersaLat Recovery

Primary DI
06009712642861
Brand
VersaTap /VersaLat Recovery
Company
ORTHO-DESIGN (PTY) LTD
Model
ADP003-2
Catalog number
ADP003-2
Device description
VersaTap™/VersaLat Recovery - EasyOut, AO Coupling
Published
2024-06-24
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
NBHAccessories, Arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009712642861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009712642861060097126428616009712642861

GMDN Terms#

Term, Definition table
TermDefinition
Screw-extraction orthopaedic reamer, reusableA surgical tool designed for overdrilling, gripping, and extracting an implanted surgical screw shaft when the screw head has become defective or detached, or the shaft has broken. It is in the form of a thin hollow metal shaft, with saw teeth at the cutting edge and a conical thread within the lumen. The device is rotated around the screw shaft to remove a thin layer of bone, either by a surgical power tool or a manual handle, until the internal thread grips the screw for removal. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
557386523
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
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
06009708899484VersaTiATP004ATP0042023-09-01
06009712641611VersaTiATP001ATP0012023-09-01
06009712641628VersaTiATP002ATP0022023-09-01
06009712641642VersaTapADP005ADP0052023-09-01
06009712641666MiniTiATP003ATP0032023-09-01
06009712642250VersaPEEKAPP001-NAPP001-N2023-09-01
06009712641581VersaTapADP001ADP0012023-08-31
06009712642434VersaTap/Lat Removal ToolADP003-1ADP003-12023-09-07
06009712642441VersaTap Tip RemovalADP004-1ADP004-12023-09-07
06009712642663VersaPEEK TapAPP001-1APP001-12023-09-07
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

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Primary DI, Brand, Company table
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10845854087558Infinity™Conmed CorporationNBH2026-06-10
20857915007815STRATOS Endo Release Kit (GEN 2) Case of 5A.M. SURGICAL, INC.NBH2026-06-10
00857915007705STRATOS (Gen2)A.M. SURGICAL, INC.NBH2026-06-05
00857915007033RetraBE Single - Gen 2 DepricatedA.M. SURGICAL, INC.NBH2026-06-04
00857915007781Retra Uni Gen 1 (5-Pack)A.M. SURGICAL, INC.NBH2026-06-04
00857915007798Retra Uni Gen 1 SingleA.M. SURGICAL, INC.NBH2026-06-04
10857915007030RETRA Single - GEN 2 DepricatedA.M. SURGICAL, INC.NBH2026-06-04
00857915007026Scope AdapterA.M. SURGICAL, INC.NBH2026-06-01
04059453163318Hermann Medizintechnik GmbHHermann Medizintechnik GmbHNBH2026-05-29
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10080196387984MedlineMEDLINE INDUSTRIES, INC.NBH2023-10-09
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