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510(k) Data Aggregation
K Number
K180807Device Name
Celling Aspiration Needle
Manufacturer
Date Cleared
2018-05-24
(57 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
SpineSmith Holdings, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Celling Aspiration Needle is intended for use in aspirating bone marrow.
Device Description
The Celling Aspiration Needle is a single-use aspiration needle comprised of a stainless steel cannula with a molded plastic handle, and a stainless steel stylet with a molded plastic handle which mates with the cannula handle when the stylet is inserted through the cannula. While holding the mated handles, the user rotates the needle using a clockwise-counter clockwise motion while applying pressure on the bone. The needle bores into the marrow cavity. Once there the stylet is removed and aspiration is accomplished by attaching a luer syringe (not included) to the needle and applying negative pressure.
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K Number
K141537Device Name
IN:C2 SPINAL FIXATION SYSTME
Manufacturer
Date Cleared
2014-11-25
(168 days)
Product Code
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
SPINESMITH HOLDINGS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IN:C2 Spinal Fixation System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. IN:C2 is a stand-alone device intended to be used with an anterior cover plate and a minimum two provided bone screws angled both cephalad and caudal with a minimum of one screw into each vertebral body. The implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.
Device Description
The IN:C2 System consists of a 'U' shaped PEEK block in multiple footprint configurations and heights. The PEEK implants contain a titanium marker intended to verify position radiologically. The IN:C2 is a stand-alone system, intended for use with its cover plate assembly and two titanium bone screws provided. The IN:C2 implant is intended to be implanted via an open anterior approach.
The anterior cover plate assembly attaches to the anterior most portion of the device, and includes housing features for placement of two bone screws angled cephalad and caudal. The cover plate assembly and integrated screws are supplemental fixation.
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