FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,850 results
13153–13176 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 10, 2000
KEYSTONE HIP
K000521 · LPH
Encore Orthopedics, Inc.
Orthopedic · 84d
Cleared May 10, 2000
COLORADO II SPINAL SYSTEM
K991031 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 408d
Cleared May 05, 2000
PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601
K000734 · KTT
Pioneer Surgical Technology
Orthopedic · 59d
Cleared May 04, 2000
SHUTTLE STOP
K000587 · LZN
Isotis NV
Orthopedic · 72d
Cleared May 04, 2000
VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT...
K000691 · HRX
Oratec Interventions, Inc.
Orthopedic · 65d
Cleared May 04, 2000
CEMSTOP CEMENT RESTRICTOR
K993841 · LZN
Encore Orthopedics, Inc.
Orthopedic · 174d
Cleared May 04, 2000
MODULAR-PLUS REVISION STEM
K994126 · LWJ
Plus Orthopedics
Orthopedic · 149d
Cleared May 01, 2000
BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B
K000506 · MAI
Arthrex, Inc.
Orthopedic · 76d
Cleared May 01, 2000
SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
K000682 · KTT
Synthes (Usa)
Orthopedic · 62d
Cleared Apr 28, 2000
SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
K000684 · KTT
Synthes (Usa)
Orthopedic · 59d
Cleared Apr 27, 2000
ASCENT KNEE REVISION FEMORAL STEM
K001010 · JWH
Biomet, Inc.
Orthopedic · 29d
Cleared Apr 26, 2000
DELTALOC ANTERIOR CERVICAL PLATE SYSTEM
K993513 · KWQ
Alphatec Mfg., Inc.
Orthopedic · 191d
Cleared Apr 26, 2000
BIOLOK SCREW
K993630 · HWC
Encore Orthopedics, Inc.
Orthopedic · 182d
Cleared Apr 24, 2000
RESPONSE 2000 HIP STEM
K000392 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 77d
Cleared Apr 24, 2000
RESPONSE 2000 CEMENTED HIP STEM
K000432 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 75d
Cleared Apr 24, 2000
MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS
K001105 · KWP
Depuyacromed
Orthopedic · 19d
Cleared Apr 18, 2000
SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE...
K000876 · MNI
Interpore Cross Intl.
Orthopedic · 29d
Cleared Apr 18, 2000
MODIFICATION TO TSRH SPINAL SYSTEM
K000991 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 21d
Cleared Apr 18, 2000
NUVASIVE TOWNLEY FACET SCREW
K994308 · MRW
Nuvasive, Inc.
Orthopedic · 119d
Cleared Apr 14, 2000
ABC CERVICAL PLATING SYSTEM
K000486 · KWQ
Aesculap, Inc.
Orthopedic · 60d
Cleared Apr 14, 2000
SYNTHES (USA) WRIST FUSION PLATES (WFP)
K000558 · LXT
Synthes (Usa)
Orthopedic · 56d
Cleared Apr 14, 2000
MODIFICATION TO EBI SPINELINK SYSTEM
K001037 · MNI
Ebi, L.P.
Orthopedic · 14d
Cleared Apr 14, 2000
HAIDER-UCR SPINAL SYSTEM
K993503 · MNH
International Advanced Medical...
Orthopedic · 182d
Cleared Apr 11, 2000
CORTEK ARTHROSCOPE
K000198 · HRX
Cortek Endoscopy, Inc.
Orthopedic · 81d