dualX SLAP HAMMER

GUDID B707125341060

DUAL X Slap Hammer

AMPLIFY SURGICAL, INC.

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable
Primary Device IDB707125341060
NIH Device Record Key5cc4d84a-c51f-4772-8453-ba37af884d88
Commercial Distribution StatusIn Commercial Distribution
Brand NamedualX SLAP HAMMER
Version Model Number12534106
Company DUNS081021000
Company NameAMPLIFY SURGICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB707125341060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B707125341060]

Moist Heat or Steam Sterilization


[B707125341060]

Moist Heat or Steam Sterilization


[B707125341060]

Moist Heat or Steam Sterilization


[B707125341060]

Moist Heat or Steam Sterilization


[B707125341060]

Moist Heat or Steam Sterilization


[B707125341060]

Moist Heat or Steam Sterilization


[B707125341060]

Moist Heat or Steam Sterilization


[B707125341060]

Moist Heat or Steam Sterilization


[B707125341060]

Moist Heat or Steam Sterilization


[B707125341060]

Moist Heat or Steam Sterilization


[B707125341060]

Moist Heat or Steam Sterilization


[B707125341060]

Moist Heat or Steam Sterilization


[B707125341060]

Moist Heat or Steam Sterilization


[B707125341060]

Moist Heat or Steam Sterilization


[B707125341060]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-04-17
Device Publish Date2019-10-15

Devices Manufactured by AMPLIFY SURGICAL, INC.

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B707125350030 - DUALX IMPLANT STERILIZATION CADDY2024-01-23 IMPLANT STERILIZATION CADDY
B707129410010140 - DUALXS T/PLIF 15 DEG x 9-12MM2024-01-23 Lordosis & Heights: 15° x 9-12mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Height (mm): 9 Expanded Height (mm)
B707NHN23010 - DUALX DUAL PORTAL ROOT RETRACTOR BAYONET2024-01-23 ROOT RETRACTOR BAYONET
B707NHN23020 - DUALX DUAL PORTAL ROOT RETRACTOR2024-01-23 ROOT RETRACTOR
B7071011140 - DUALX DUAL PORTAL SUCTION TUBE W/ STYLET2023-08-18 SUCTION TUBE W/ STYLET
B707125341170 - DualX SLAP HAMMER ADAPTER2023-08-18 DualX SLAP HAMMER ADAPTER
B707125341420 - DualXS IMPLANT HOLDER2023-08-18 DUALXS IMPLANT HOLDER

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