FDA.reportPublic FDA data

PunchTac

Primary DI
00854629006581
Brand
PunchTac
Company
DUNAMIS MEDICAL, LLC
Model
DFX0043A
Catalog number
DFX0043A
Device description
4.75 PunchTac Threaded Anchor PEEK, Preleoaded with Two 2mm Fiber Connect (UHMWPE)
Published
2018-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
K160996000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160996000Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC2016-07-06MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854629006581PackageGS15In Commercial Distribution
00854629006574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854629006581008546290065818546290065810854629006581
00854629006574008546290065748546290065740854629006574

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
731-217-2533rajchavan@dunamismedical.com

Regulatory Flags#

DUNS number
079471560
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10854629006847Fastloop™ WhiteDFX24SLW2022-03-03
10854629006854Fastloop™ GreenDFX24SLG2022-03-03
00850052601317Olecranon Transporter™ Repair KitOL-2000OL-20002025-04-29
00850052601294Force DFX Suture Loop -Xtreme™DFX34XSLDFX0034S2025-04-10
40854629006916Orca™ Xtreme Knotless ButtonAB-6900AB-69002024-01-31
00854629006956Enofix ™ with Constrictor® Technology Syndesmotic Fixation Kit 3500-00-00013500-00-00012023-07-31
00850052601263Constrictor® Mini 2.0 Syndesmosis Repair Kit AB-3700AB-37002024-09-19
00850052601270Constrictor® 2.0 Syndesmosis Repair Kit AB-2700AB-27002024-09-19
00854629006789Constrictor® Mini Syndesmosis Repair Kit AB-3200AB-32002024-09-19
00850052601256Micro Constrictor ®X Repair KitAB-8700AB-87002024-09-19
00850052601249Orca™ Implantation Kit AB-6250AB-62502024-06-20
00850052601072Hallux GuideDU1000DU10002024-06-10
00850052601089CMC SpacerDNS000/DNS001DNS000/DNS0012024-06-10
00850052601096CMC GuideDU3000DU30002024-06-10
00850052601157Threaded Driver 100161010016102024-06-10
00850052601232Micro Constrictor® Implantation Kit AB-8250AB-69502024-06-10
00850052601225Orca Xtreme ™ Kit Knotless ButtonAB-6925AB-69252024-03-14
00850052601218Orca™ Xtreme Implantation Kit AB-6950AB-69502024-02-13
00854629006147PunchTac 3mm Anchor PEEKDFX0028ADFX0028A2017-04-11
00854629006161PunchTac 3.5mm Anchor PEEKDFX0029ADFX0029A2017-04-11

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Primary DI, Brand, Company table
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