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
7321–7344 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 27, 2012
MERETE LOCKING BONE PLATE SYSTEM III
K120787 · HRS
Merete Medical GmbH
Orthopedic · 257d
Cleared Nov 27, 2012
OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE +...
K121989 · MQV
Exactech, Inc.
Orthopedic · 144d
Cleared Nov 26, 2012
PICCOLO COMPOSITE PLATE SYSTEM
K120409 · HRS
CarboFix Orthopedics , Ltd.
Orthopedic · 291d
Cleared Nov 23, 2012
G7 ACETABULAR SYSTEM
K121874 · PBI
Biomet Manufacturing Corp
Orthopedic · 149d
Cleared Nov 21, 2012
STR GRAFT
K121216 · OWW
Soft Tissue Regeneration, Inc.
Orthopedic · 212d
Cleared Nov 21, 2012
CORIN TRINITY-I ACETABULAR SHELL
K122305 · LZO
Corin USA
Orthopedic · 112d
Cleared Nov 20, 2012
EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT
K121220 · KWS
Exactech, Inc.
Orthopedic · 211d
Cleared Nov 20, 2012
VICEROY SPINAL SYSTEM
K122229 · NKB
Torrey Spine
Orthopedic · 117d
Cleared Nov 20, 2012
ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
K122596 · HWC
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Nov 20, 2012
S-LOK PSS SYSTEM
K122931 · MNI
Spinal USA
Orthopedic · 57d
Cleared Nov 20, 2012
COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM
K123297 · MBF
Biomet Manufactuting Corp.
Orthopedic · 29d
Cleared Nov 19, 2012
LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ...
K121494 · HRS
Aap Implantate AG
Orthopedic · 182d
Cleared Nov 19, 2012
ZOU ANTERIOR LUMBAR PLATE SYSTEM
K121791 · KWQ
Corelink, LLC
Orthopedic · 153d
Cleared Nov 19, 2012
ACUMED PELVIC BONE PLATE SYSTEM
K122538 · HRS
Acumed, LLC
Orthopedic · 90d
Cleared Nov 16, 2012
PRO-LINK CERVICAL SPACER SYSTEM
K121151 · OVE
Life Spine, Inc.
Orthopedic · 214d
Cleared Nov 16, 2012
INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE
K122008 · OVE
Incite Innovation, LLC
Orthopedic · 130d
Cleared Nov 16, 2012
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE
K122529 · HSX
Zimmer, Inc.
Orthopedic · 88d
Cleared Nov 16, 2012
CD HORIZON SPIRE Z SPINAL SYSTEM
K123246 · NKB
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Nov 15, 2012
SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY
K113728 · MBP
Hans Biomed Corp.
Orthopedic · 332d
Cleared Nov 15, 2012
NAVIGATION SOFTWARE HIP-UNIVERSAL
K122011 · OLO
Brainlab AG
Orthopedic · 129d
Cleared Nov 14, 2012
KLS MARTIN RECON TALON
K122860 · HRS
KLS-Martin L.P.
Orthopedic · 57d
Cleared Nov 13, 2012
VERTIFLEX DIRECT DECOMPRESSION SYSTEM
K122662 · HRX
Vertiflex, Inc.
Orthopedic · 74d
Cleared Nov 09, 2012
H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS
K112091 · MEH
Lima Corporate S.P.A.
Orthopedic · 477d
Cleared Nov 09, 2012
MICRO/MINI N-PK(F) BONE ANCHOR
K121354 · MBI
Anulex Technologies, Inc.
Orthopedic · 189d