Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

49 results for "Spinal Elements, Inc."
25–48 of 49
Search insights Median review: 115d Cleared: 100% Top manufacturer: Spinal Elements, Inc. Lead specialty: Orthopedic
Cleared Sep 03, 2015
Lotus Posterior Cervical/Thoracic Spinal System
K151705 · NKG
Spinal Elements, Inc.
Orthopedic · 71d
Cleared Jun 03, 2015
Mercury Spinal System
K151215 · NKB
Spinal Elements, Inc.
Orthopedic · 28d
Cleared May 19, 2015
Lucent
K150061 · MAX
Spinal Elements, Inc.
Orthopedic · 126d
Cleared Dec 10, 2014
Crystal ®
K133218 · OVE
Spinal Elements, Inc.
Orthopedic · 418d
Cleared Aug 22, 2014
MERCURY SPINAL SYSTEM
K141372 · NKB
Spinal Elements, Inc.
Orthopedic · 87d
Cleared Oct 24, 2013
LOTUS
K131427 · KWP
Spinal Elements, Inc.
Orthopedic · 160d
Cleared Feb 21, 2013
LUCENT
K122967 · MAX
Spinal Elements, Inc.
Orthopedic · 149d
Cleared Jan 10, 2013
SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
K122771 · OVE
Spinal Elements, Inc.
Orthopedic · 122d
Cleared Jul 30, 2012
SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM
K120467 · NKB
Spinal Elements, Inc.
Orthopedic · 166d
Cleared Jul 03, 2012
SPINAL ELEMENTS CERCLAGE SYSTEM
K120177 · JDQ
Spinal Elements, Inc.
Orthopedic · 165d
Cleared May 23, 2012
LUCENT OR LUCENT MAGNUM
K110632 · MAX
Spinal Elements, Inc.
Orthopedic · 446d
Cleared Oct 14, 2010
SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM
K101848 · KWQ
Spinal Elements, Inc.
Orthopedic · 105d
Cleared Jul 01, 2009
MERCURY SPINAL SYSTEM
K091587 · NKB
Spinal Elements, Inc.
Orthopedic · 29d
Cleared Feb 18, 2009
AXXION LIGHT GUIDE
K082992 · FST
Spinal Elements, Inc.
General & Plastic Surgery · 134d
Cleared Feb 13, 2009
LUCENT MAGNUM
K083475 · OVD
Spinal Elements, Inc.
Orthopedic · 81d
Cleared Jan 22, 2009
MERCURY SPINAL SYSTEM
K082353 · NKB
Spinal Elements, Inc.
Orthopedic · 160d
Cleared Dec 03, 2008
MERCURY SPINAL SYSTEM
K083230 · NKB
Spinal Elements, Inc.
Orthopedic · 30d
Cleared Sep 11, 2008
LUCENT MAGNUM+
K081711 · OVD
Spinal Elements, Inc.
Orthopedic · 86d
Cleared Aug 05, 2008
MODIFICATION TO LUCENT
K081968 · MAX
Spinal Elements, Inc.
Orthopedic · 26d
Cleared Jul 14, 2008
SPINAL ELEMENTS BUTTRESS PLATE SYSTEM
K081418 · KWQ
Spinal Elements, Inc.
Orthopedic · 55d
Cleared Jan 24, 2008
CRYSTAL
K073351 · ODP
Spinal Elements, Inc.
Orthopedic · 56d
Cleared Dec 26, 2007
LUCENT MAGNUM
K073348 · MAX
Spinal Elements, Inc.
Orthopedic · 27d
Cleared Nov 09, 2007
LUCENT
K071724 · MAX
Spinal Elements, Inc.
Orthopedic · 137d
Cleared Oct 23, 2007
MOSAIC DEVICES
K071833 · OVE
Spinal Elements, Inc.
Orthopedic · 112d