FDA Product Code
FDA Product Code LXH — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.4540
510(k) Clearances — 58 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K192873 | SX-One MicroKnife | Sonex Health, Inc. | 2019-12-20 | Traditional | PDF ↗ |
| K140414 | IMBIBE NEEDLE | Orthovita, Inc. | 2014-04-01 | Traditional | PDF ↗ |
| K101609 | SELF RETAINING SOFT TISSUE RETRACTOR | Koros USA, Inc. | 2010-12-09 | Traditional | PDF ↗ |
| K001507 | MICROPERFORATION INSTRUMENT | Smith & Nephew, Inc. | 2000-06-14 | Traditional | PDF ↗ |
| K952495 | ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM | Orthopedic Systems, Inc. | 1996-01-22 | Traditional | PDF ↗ |
| K943873 | ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY | Orthomet, Inc. | 1995-04-26 | Traditional | PDF ↗ |
| K944188 | SPINAL MARKER | Leibinger L.P. | 1995-04-13 | Traditional | PDF ↗ |
| K941896 | STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR | Depuy, Inc. | 1994-11-07 | Traditional | PDF ↗ |
| K941711 | HYPERFLEX FLEXIBLE GUIDEWIRES | Linvatec Corp. | 1994-08-26 | Traditional | PDF ↗ |
| K941605 | STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH | Stryker Corp. | 1994-08-05 | Traditional | PDF ↗ |
| K933772 | PUNCH SURGICAL | Mahe-Medizintechnik | 1994-02-01 | Traditional | PDF ↗ |
| K933242 | SOFAMOR ORTHOPAEDIC INSTRUMENTS | Danek Medical, Inc. | 1994-01-28 | Traditional | PDF ↗ |
| K934260 | BARRIER BONE WAX APPLICATOR | Phillips Pharmaceuticals, Inc. | 1994-01-26 | Traditional | PDF ↗ |
| K931846 | BIO-PREP | Biomedical Devices, Inc. | 1994-01-21 | Traditional | PDF ↗ |
| K930028 | CALMPS: BONE, MASTIN, LEWIN, BRAND | Thomasville Medical Assoc. | 1993-02-16 | Traditional | PDF ↗ |
| K921402 | SURGICAL INSTRUMENT, DISPOSABLE | Macro Medical, Inc. | 1992-06-04 | Traditional | PDF ↗ |
| K921645 | AMSEN SPINE IMPACTOR INSTRUMENTS | Advanced Med/Surg, Inc. | 1992-06-03 | Traditional | PDF ↗ |
| K921642 | AMSEN DOUBLE-ENDED FORAMINAL PROBE | Advanced Med/Surg, Inc. | 1992-06-03 | Traditional | PDF ↗ |
| K921644 | AMSEN HOCKEY STICK CHISEL | Advanced Med/Surg, Inc. | 1992-06-03 | Traditional | PDF ↗ |
| K921643 | AMSEN POSTERIOR DISC EVACUATOR | Advanced Med/Surg, Inc. | 1992-06-03 | Traditional | PDF ↗ |
| K901289 | RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS | Mumtaz I. Malik | 1990-09-28 | Traditional | PDF ↗ |
| K901511 | CHISEL, BONE, SURGICAL | Mumtaz I. Malik | 1990-09-28 | Traditional | PDF ↗ |
| K901420 | VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8 | Mumtaz I. Malik | 1990-09-28 | Traditional | PDF ↗ |
| K901521 | OSTEOTOMES OF VARIOUS TYPES | Mumtaz I. Malik | 1990-09-28 | Traditional | PDF ↗ |
| K902819 | LAMINECTOMY ROGEUR | Ruggles Corp. | 1990-08-09 | Traditional | PDF ↗ |
| K903257 | DRIVER/EXTRACTOR | Onyx Medical Corp. | 1990-07-30 | Traditional | PDF ↗ |
| K903270 | T-HANDLE HEX WRENCH | Onyx Medical Corp. | 1990-07-30 | Traditional | PDF ↗ |
| K903247 | ADJUSTABLE ANGLE GUIDE | Onyx Medical Corp. | 1990-07-30 | Traditional | PDF ↗ |
| K895172 | KRONNER SACRAL PIN GUIDE | Kronner Medical | 1989-09-12 | Traditional | PDF ↗ |
| K891903 | COHN TARGETEER | Orthopedic Systems, Inc. | 1989-05-15 | Traditional | PDF ↗ |
| K890161 | THOMPSON TYPE RASP W/TOMMY BAR | Dhason Brothers, Inc. | 1989-02-13 | Traditional | PDF ↗ |
| K890160 | GOUGES FOR FEMORAL HEADS | Dhason Brothers, Inc. | 1989-02-13 | Traditional | PDF ↗ |
| K890157 | FORCEPS | Dhason Brothers, Inc. | 1989-02-13 | Traditional | PDF ↗ |
| K890163 | AUSTIN MOORE HALLOW CHISEL | Dhason Brothers, Inc. | 1989-02-13 | Traditional | PDF ↗ |
| K890158 | RETRACTORS | Dhason Brothers, Inc. | 1989-02-13 | Traditional | PDF ↗ |
| K890164 | HUDSON BRACE W/BURRS | Dhason Brothers, Inc. | 1989-02-13 | Traditional | PDF ↗ |
| K890156 | IMPACTOR FOR FEMORAL HEAD | Dhason Brothers, Inc. | 1989-02-13 | Traditional | PDF ↗ |
| K890166 | RONGUER-ORTHOPEDIC | Dhason Brothers, Inc. | 1989-02-13 | Traditional | PDF ↗ |
| K890162 | EXTRACTOR FOR AUSTIN MOORE FEMORAL HEAD | Dhason Brothers, Inc. | 1989-02-13 | Traditional | PDF ↗ |
| K890168 | RETRACTOR, SELF-RETAINING | Dhason Brothers, Inc. | 1989-02-13 | Traditional | PDF ↗ |
| K883694 | TENSIOMETER | W. L. Gore & Associates, Inc. | 1988-11-22 | Traditional | PDF ↗ |
| K882077 | MICRODISCECTOMY CURRETTES | Karlin Technology, Inc. | 1988-06-17 | Traditional | PDF ↗ |
| K882069 | SPINAL DISTRACTORS, SPANNERS | Karlin Technology, Inc. | 1988-06-17 | Traditional | PDF ↗ |
| K880413 | PATELLAR TENDON GRAFT GUIDE | Concept, Inc. | 1988-03-04 | Traditional | PDF ↗ |
| K860131 | ACROMED SPINAL SURGERY INSTRUMENTS | Buckman Co., Inc. | 1986-03-19 | Traditional | PDF ↗ |
| K844595 | ORTHOPEDIC CUSTOM SURGICAL KIT | Xanmed Corp. | 1985-08-21 | Traditional | PDF ↗ |
| K843942 | HENNING MENISCAL SUTURE KIT | Stryker Corp. | 1985-04-15 | Traditional | PDF ↗ |
| K841969 | 6.5MM HEX HANDLE | Stainless Mfg., Inc. | 1984-06-19 | Traditional | PDF ↗ |
| K841970 | CAMELBACK HANDLE-K841969-LABELING | Stainless Mfg., Inc. | 1984-06-19 | Traditional | PDF ↗ |
| K834108 | NEEDLE BENDER TX8225 | Today'S Machining & Design, Inc. | 1984-03-12 | Traditional | PDF ↗ |
| K834369 | CRANE MENISCAL SUTURE SET | Acufex Microsurgical, Inc. | 1984-02-27 | Traditional | PDF ↗ |
| K834370 | MULHOLLAN ARTHROSCOPIC NEEDLE CARRIER | Acufex Microsurgical, Inc. | 1984-02-27 | Traditional | PDF ↗ |
| K833943 | MENISCAL SUTURING SYSTEM | Dyonics, Inc. | 1984-02-27 | Traditional | PDF ↗ |
| K813000 | DISPOSABLE ARTHROSCOPY CANNULA SET | Clinical Technology Corp. | 1982-01-22 | Traditional | PDF ↗ |
| K803127 | HOWMEDICA KNEE BRUSH | Howmedica Corp. | 1981-02-10 | Traditional | PDF ↗ |
| K810267 | FEMORAL CANAL BRUSH | Richard'S Medical Equip., Inc. | 1981-02-09 | Traditional | PDF ↗ |
| K802694 | JACOB CHUCK | Richard Wolf Medical Instruments Corp. | 1980-11-12 | Traditional | PDF ↗ |
| K792670 | SMITH SUBTALAR PEG | Dow Corning Wright | 1980-02-22 | Traditional | PDF ↗ |
Product code LXH · Class I · Orthopedic. Data: openFDA.