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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
14977–15000 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 17, 1995
SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX]
K951904 · JDO
Synthes (Usa)
Orthopedic · 84d
Cleared Jul 17, 1995
FORGED CEMENTED STEM
K952191 · JDI
Encore Orthopedics, Inc.
Orthopedic · 69d
Cleared Jul 17, 1995
FOUNDATION TEXTURED STEM
K952297 · LWJ
Encore Orthopedics, Inc.
Orthopedic · 62d
Cleared Jul 14, 1995
REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT
K951843 · HRX
Future Medical Systems, Inc.
Orthopedic · 85d
Cleared Jul 14, 1995
CITATION MULTIPLE USE DELTA SCOPE
K951941 · HRX
Citation Medical Corp.
Orthopedic · 80d
Cleared Jul 13, 1995
CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM
K940631 · MNH
Cross Medical Products, Inc.
Orthopedic · 514d
Cleared Jul 13, 1995
METALLIC RADIAL HEAD IMPLANTS
K944507 · KWI
Wrightmedicaltechnologyinc
Orthopedic · 301d
Cleared Jul 13, 1995
GLIDING NAIL
K951809 · KTT
Encore Orthopedics, Inc.
Orthopedic · 86d
Cleared Jul 13, 1995
BIOMECHANIC LOW-PROFILE CABLE SYSTEM
K951844 · JDQ
Biomechanic, Inc.
Orthopedic · 84d
Cleared Jul 13, 1995
TENTATIVELY POLARUS EX ROD
K952534 · HSB
Acu Med, Inc.
Orthopedic · 42d
Cleared Jul 12, 1995
BONE FIXATION NAIL
K943855 · JDS
Acu Med, Inc.
Orthopedic · 338d
Cleared Jul 11, 1995
FOUNDATION POROUS STEM
K935263 · JDI
Encore Orthopedics, Inc.
Orthopedic · 615d
Cleared Jul 11, 1995
MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM
K942263 · HSX
Zimmer, Inc.
Orthopedic · 428d
Cleared Jul 11, 1995
J.B.S. CERVICAL SPINE SYSTEM
K942432 · KWP
J.B.S., S.A.
Orthopedic · 417d
Cleared Jul 11, 1995
ANSPACH SUTURE ANCHOR
K945525 · HWC
The Anspach Effort, Inc.
Orthopedic · 243d
Cleared Jul 11, 1995
CRUCIATE RETAINING (AUGMENTABLE) AND CONSTRAINED CONDYLAR KNEE (CCK)
K946150 · JWH
Zimmer, Inc.
Orthopedic · 207d
Cleared Jul 11, 1995
ABSORBABLE ACETABULAR SCREW
K946347 · HWC
Zimmer, Inc.
Orthopedic · 193d
Cleared Jul 11, 1995
OGDEN ANCHOR
K950875 · HWC
American Medical Electronics, Inc.
Orthopedic · 133d
Cleared Jul 11, 1995
DURACON RECESSED PATELLA
K951655 · JWH
Howmedica Corp.
Orthopedic · 92d
Cleared Jul 11, 1995
CEMENTRALIZER DISTAL STEM CENTRALIZER
K951930 · LZN
Depuy, Inc.
Orthopedic · 97d
Cleared Jul 10, 1995
DEPUY SET SCREW
K950833 · HWC
Depuy, Inc.
Orthopedic · 136d
Cleared Jul 06, 1995
F-230 POROUS FEMORAL HIP STEM (CEMENTLESS)
K941612 · LPH
Implex Corp.
Orthopedic · 458d
Cleared Jul 06, 1995
FIXATION PINS/WIRES
K943856 · HTY
Acu Med, Inc.
Orthopedic · 332d
Cleared Jul 06, 1995
PROFIX CONFORMING PLUS TIBIAL INSERT
K946236 · KWH
Smith & Nephew Richards, Inc.
Orthopedic · 196d