FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,766 results
7465–7488 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 10, 2012
LANX SPINAL FIZATION SYSTEM
K121316 · NKB
Lanx, Inc.
Orthopedic · 131d
Cleared Sep 10, 2012
TAPERSET HIP SMALL STEMS
K121935 · LPH
Consensus Orthopedics, Inc.
Orthopedic · 70d
Cleared Sep 07, 2012
SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS
K121714 · HSD
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Sep 06, 2012
LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF...
K113648 · HRS
Aap Implantate AG
Orthopedic · 269d
Cleared Sep 06, 2012
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
K121974 · HSX
Conformis, Inc.
Orthopedic · 63d
Cleared Sep 06, 2012
MAXLOCK EXTREME SYSTEM
K122005 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 59d
Cleared Sep 06, 2012
DEPUY CTA REVERSE SHOULDER SYSTEM
K122442 · PHX
Depuy France
Orthopedic · 27d
Cleared Sep 05, 2012
METS SMILES TOTAL KNEE REPLACEMENT
K120992 · KRO
Stanmore Implants Worldwide , Ltd.
Orthopedic · 156d
Cleared Sep 05, 2012
RELIANCE ANTERIOR CERVICAL PLATE SYSTEM
K122216 · KWQ
Reliance Medical Systems, LLC
Orthopedic · 42d
Cleared Sep 04, 2012
ORTHOFIX GALAXY FIXATION SYSTEM
K113770 · KTT
Orthofix Srl
Orthopedic · 257d
Cleared Sep 04, 2012
IOI TOTAL HIP
K121034 · LPH
Iconacy Orthopedic Implants, LLC
Orthopedic · 152d
Cleared Sep 04, 2012
ALAMO P
K122047 · MAX
Alliance Partners, LLC
Orthopedic · 54d
Cleared Aug 31, 2012
STALIF C
K120819 · OVE
Centinel Spine, Inc.
Orthopedic · 165d
Cleared Aug 30, 2012
LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF...
K113652 · HRS
Aap Implantate AG
Orthopedic · 262d
Cleared Aug 30, 2012
CERVICAL CAGE
K122444 · ODP
Eisertech, LLC
Orthopedic · 20d
Cleared Aug 29, 2012
NEURO VENTION LAMINPLASTY PLATING SYSTEM
K121276 · NQW
Neurovention, LLC
Orthopedic · 124d
Cleared Aug 29, 2012
CAPSTONE SPINAL SYSTEM
K121760 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 75d
Cleared Aug 29, 2012
STAXX XD SYSTEM
K121889 · MQP
Spine Wave, Inc.
Orthopedic · 62d
Cleared Aug 29, 2012
TETRIS II
K122317 · MAX
Signus Medizintechnik GmbH
Orthopedic · 28d
Cleared Aug 28, 2012
XIA 3 SPINAL SYSTEM
K113666 · NKB
Stryker Spine
Orthopedic · 259d
Cleared Aug 28, 2012
INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY
K121482 · HRX
Theken Spine, LLC
Orthopedic · 102d
Cleared Aug 28, 2012
SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING
K122296 · LZO
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Aug 24, 2012
ZIMMER TRABECULAR METAL TOTAL ANKLE
K120906 · HSN
Zimmer, Inc.
Orthopedic · 151d
Cleared Aug 24, 2012
LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE,...
K121103 · NKB
Ldr Spine USA, Inc.
Orthopedic · 135d