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
13825–13848 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 05, 1998
PRE-POWDERED NITRILE EXAMINATION GLOVES
K974442 · LZY
P.T. Latexindo Tobaperkasa
Orthopedic · 41d
Cleared Jan 02, 1998
FOUNDATION FRACTURE STEM
K973809 · JDI
Encore Orthopedics, Inc.
Orthopedic · 88d
Cleared Dec 29, 1997
AESCULAP HILAN MOTOR SYSTEM
K973736 · HWE
Aesculap, Inc.
Orthopedic · 89d
Cleared Dec 24, 1997
OMEGA 21 SYSTEM
K973683 · MNH
Ebi Electro Biology
Orthopedic · 89d
Cleared Dec 24, 1997
VERSYS HIP SYSTEM BEADED HIP PROSTHESIS
K973714 · LPH
Zimmer, Inc.
Orthopedic · 86d
Cleared Dec 23, 1997
DISTAL CENTRALIZER, EXETER II HIP SYSTEM
K974054 · JDI
Howmedica, Inc.
Orthopedic · 57d
Cleared Dec 19, 1997
THE POSTERIOR STABILISED NUFFIELD TOTAL KNEE SYSTEM
K973595 · JWH
Corin USA
Orthopedic · 88d
Cleared Dec 19, 1997
NATURAL-HIP POROUS STEM WITH OFFSET
K973675 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 84d
Cleared Dec 19, 1997
NATURAL-HIP COCR OFFSET STEM
K973681 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 84d
Cleared Dec 19, 1997
REVELATION POROUS HIP STEM
K973685 · LPH
Encore Orthopedics, Inc.
Orthopedic · 84d
Cleared Dec 19, 1997
ORTHOFIX FEMORAL NAILING SYTEM
K973944 · HSB
Orthofix Srl
Orthopedic · 64d
Cleared Dec 19, 1997
CERCLAGE CABLE WITH HEX BUTTON
K974016 · JDQ
Pioneer Surgical Technology
Orthopedic · 58d
Cleared Dec 19, 1997
SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM
K974020 · JDQ
Spinal Concepts, Inc.
Orthopedic · 58d
Cleared Dec 18, 1997
LATERAL FLARE INTERNAL COLLAR (LFIC)
K971900 · LWJ
Pro-Lfic, LLC
Orthopedic · 209d
Cleared Dec 18, 1997
FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES
K973614 · KWL
Encore Orthopedics, Inc.
Orthopedic · 86d
Cleared Dec 18, 1997
FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA
K973672 · JWH
Encore Orthopedics, Inc.
Orthopedic · 83d
Cleared Dec 12, 1997
ADVANCE MODULAR TIBIAL COMPONENT
K973524 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 86d
Cleared Dec 09, 1997
CLINITEX STOCKINETTE
K973417 · LGF
Clinitex Medical Corp.
Orthopedic · 90d
Cleared Dec 09, 1997
CLINITEX CAST PADDING
K973420 · LGF
Clinitex Medical Corp.
Orthopedic · 90d
Cleared Dec 09, 1997
OSTEO BOS SYSTEM PRODUCT LINE EXTENSION
K973438 · HRS
Osteonics Corp.
Orthopedic · 90d
Cleared Dec 08, 1997
OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT
K973406 · JWH
Osteonics Corp.
Orthopedic · 90d
Cleared Dec 08, 1997
NATURAL-KNEE II CONSTRAINED KNEE SYSTEM
K973412 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 90d
Cleared Dec 05, 1997
MERIDIAN TITANIUM FEMORAL STEMS
K972228 · LZO
Howmedica, Inc.
Orthopedic · 175d
Cleared Dec 05, 1997
OVAL SHAPES
K973385 · HXA
Technical Products, Inc.
Orthopedic · 88d