510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Spine Smith Partners L.P.

Austin, TX, US

Spine Smith Partners L.P. appears in FDA device records in Austin, TX. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.

FDA records held for this company

510(k) clearances
12
PMA records
0
Recall records
2
Registered establishments
0

FDA records under these names

1 name

FDA records resolved to Spine Smith Partners L.P. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Spine Smith Holdings, LLC510(k), enforcement report, recall

510(k) clearance history

FDA records hold 12 510(k) clearances for Spine Smith Partners L.P. between 2008 and 2020. The busiest year on record is 2008, with 4. The most recent is 2020, with 1.

Clearances by year, as a table
510(k) clearance decisions for Spine Smith Partners L.P., by decision year
YearClearances
20084
20091
20102
20122
20141
20181
20201
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K193465CorticaLINK Spinal Fusion PlatformNKBSubstantially Equivalent
K180807Celling Aspiration NeedleKNWSubstantially Equivalent
K141537IN:C2 SPINAL FIXATION SYSTMEOVESubstantially Equivalent
K122630IN:C2 SPINAL FIXATION SYSTEMOVESubstantially Equivalent
K122168VISUALIF CHALLENGING ACCESS PLATEOVDSubstantially Equivalent
K102090SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEMOVDSubstantially Equivalent
K101085SPINESMITH CYNCH SPINAL SYSTEMMAXSubstantially Equivalent
K090376SPINESMITH CYNCH SPINAL SYSTEMMAXSubstantially Equivalent
K082821SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially Equivalent
K081132SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially Equivalent
K080971SPINESMITH CIMPLICITY SPINAL SYSTEMMQPSubstantially Equivalent
K073320CIMPLICITY SPINAL SYSTEMODPSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2258-2013VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach.The product has the potential to be laser marked as a Medium when it actually is a Small.Class IITerminated
Z-0932-2013Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation.Implants were incorrectly laser marked as 23mm instead of 28mm.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain