Product Code: LXH
FDA class 1
21 CFR 888.4540
Orthopedic Manual Surgical Instrument
Orthopedic
The Orthopedic Manual Surgical Instrument (product code LXH) encompasses hand-held, non-powered tools used during orthopedic surgical procedures, such as chisels, osteotomes, curettes, and other manual instruments that do not apply significant energy to the patient. Regulated under 21 CFR 888.4540 and classified as a Class 1 device, it is subject only to general controls and falls under the Orthopedic medical specialty. The device is not an implant, is not life-sustaining, and is not GMP-exempt.
510(k)s
58
FEI Numbers
1140
Registration Numbers
1140
Unique Applicants
36
Years Active
40
Basic Information
- Product Code
- LXH
- Device Class
- FDA class 1
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
Loading...
Related 510(k) Clearances
This FDA classification is associated with 58 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K192873 | SX-One MicroKnife | Dec 20, 2019 | Substantially Equivalent | Sonex Health, Inc. |
| K140414 | IMBIBE NEEDLE | Apr 01, 2014 | Substantially Equivalent | ORTHOVITA, INC. |
| K101609 | SELF RETAINING SOFT TISSUE RETRACTOR | Dec 09, 2010 | Substantially Equivalent | KOROS USA, INC. |
| K001507 | MICROPERFORATION INSTRUMENT | Jun 14, 2000 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K952495 | ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM | Jan 22, 1996 | Substantially Equivalent | ORTHOPEDIC SYSTEMS, INC. |
| K943873 | ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY | Apr 26, 1995 | Substantially Equivalent | ORTHOMET, INC. |
| K944188 | SPINAL MARKER | Apr 13, 1995 | Substantially Equivalent | LEIBINGER L.P. |
| K941896 | STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR | Nov 07, 1994 | Substantially Equivalent | DEPUY, INC. |
| K941711 | HYPERFLEX FLEXIBLE GUIDEWIRES | Aug 26, 1994 | Substantially Equivalent | LINVATEC CORP. |
| K941605 | STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH | Aug 05, 1994 | Substantially Equivalent | STRYKER CORP. |
| K933772 | PUNCH SURGICAL | Feb 01, 1994 | Substantially Equivalent | MAHE-MEDIZINTECHNIK |
| K933242 | SOFAMOR ORTHOPAEDIC INSTRUMENTS | Jan 28, 1994 | Substantially Equivalent | DANEK MEDICAL, INC. |
| K934260 | BARRIER BONE WAX APPLICATOR | Jan 26, 1994 | Substantially Equivalent | PHILLIPS PHARMACEUTICALS, INC. |
| K931846 | BIO-PREP | Jan 21, 1994 | Substantially Equivalent | BIO MEDICAL DEVICES, INC. |
| K930028 | CALMPS: BONE, MASTIN, LEWIN, BRAND | Feb 16, 1993 | Substantially Equivalent | THOMASVILLE MEDICAL ASSOC. |
| K921402 | SURGICAL INSTRUMENT, DISPOSABLE | Jun 04, 1992 | Substantially Equivalent | MACRO MEDICAL, INC. |
| K921645 | AMSEN SPINE IMPACTOR INSTRUMENTS | Jun 03, 1992 | Substantially Equivalent | ADVANCED MED/SURG, INC. |
| K921644 | AMSEN HOCKEY STICK CHISEL | Jun 03, 1992 | Substantially Equivalent | ADVANCED MED/SURG, INC. |
| K921643 | AMSEN POSTERIOR DISC EVACUATOR | Jun 03, 1992 | Substantially Equivalent | ADVANCED MED/SURG, INC. |
| K921642 | AMSEN DOUBLE-ENDED FORAMINAL PROBE | Jun 03, 1992 | Substantially Equivalent | ADVANCED MED/SURG, INC. |
| K901521 | OSTEOTOMES OF VARIOUS TYPES | Sep 28, 1990 | Substantially Equivalent | MUMTAZ I. MALIK |
| K901511 | CHISEL, BONE, SURGICAL | Sep 28, 1990 | Substantially Equivalent | MUMTAZ I. MALIK |
| K901420 | VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8 | Sep 28, 1990 | Substantially Equivalent | MUMTAZ I. MALIK |
| K901289 | RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS | Sep 28, 1990 | Substantially Equivalent | MUMTAZ I. MALIK |
| K902819 | LAMINECTOMY ROGEUR | Aug 09, 1990 | Substantially Equivalent | RUGGLES CORP. |
| K903270 | T-HANDLE HEX WRENCH | Jul 30, 1990 | Substantially Equivalent | ONYX MEDICAL CORP. |
| K903257 | DRIVER/EXTRACTOR | Jul 30, 1990 | Substantially Equivalent | ONYX MEDICAL CORP. |
| K903247 | ADJUSTABLE ANGLE GUIDE | Jul 30, 1990 | Substantially Equivalent | ONYX MEDICAL CORP. |
| K895172 | KRONNER SACRAL PIN GUIDE | Sep 12, 1989 | Substantially Equivalent | KRONNER MEDICAL |
| K891903 | COHN TARGETEER | May 15, 1989 | Substantially Equivalent | ORTHOPEDIC SYSTEMS, INC. |
| K890168 | RETRACTOR, SELF-RETAINING | Feb 13, 1989 | Substantially Equivalent | DHASON BROTHERS, INC. |
| K890166 | RONGUER-ORTHOPEDIC | Feb 13, 1989 | Substantially Equivalent | DHASON BROTHERS, INC. |
| K890164 | HUDSON BRACE W/BURRS | Feb 13, 1989 | Substantially Equivalent | DHASON BROTHERS, INC. |
| K890163 | AUSTIN MOORE HALLOW CHISEL | Feb 13, 1989 | Substantially Equivalent | DHASON BROTHERS, INC. |
| K890162 | EXTRACTOR FOR AUSTIN MOORE FEMORAL HEAD | Feb 13, 1989 | Substantially Equivalent | DHASON BROTHERS, INC. |
| K890161 | THOMPSON TYPE RASP W/TOMMY BAR | Feb 13, 1989 | Substantially Equivalent | DHASON BROTHERS, INC. |
| K890160 | GOUGES FOR FEMORAL HEADS | Feb 13, 1989 | Substantially Equivalent | DHASON BROTHERS, INC. |
| K890158 | RETRACTORS | Feb 13, 1989 | Substantially Equivalent | DHASON BROTHERS, INC. |
| K890157 | FORCEPS | Feb 13, 1989 | Substantially Equivalent | DHASON BROTHERS, INC. |
| K890156 | IMPACTOR FOR FEMORAL HEAD | Feb 13, 1989 | Substantially Equivalent | DHASON BROTHERS, INC. |
| K883694 | TENSIOMETER | Nov 22, 1988 | Substantially Equivalent | W.L. GORE & ASSOCIATES,INC |
| K882077 | MICRODISCECTOMY CURRETTES | Jun 17, 1988 | Substantially Equivalent | KARLIN TECHNOLOGY, INC. |
| K882069 | SPINAL DISTRACTORS, SPANNERS | Jun 17, 1988 | Substantially Equivalent | KARLIN TECHNOLOGY, INC. |
| K880413 | PATELLAR TENDON GRAFT GUIDE | Mar 04, 1988 | Substantially Equivalent | CONCEPT, INC. |
| K860131 | ACROMED SPINAL SURGERY INSTRUMENTS | Mar 19, 1986 | Substantially Equivalent | BUCKMAN CO., INC. |
| K844595 | ORTHOPEDIC CUSTOM SURGICAL KIT | Aug 21, 1985 | Substantially Equivalent | XANMED CORP. |
| K843942 | HENNING MENISCAL SUTURE KIT | Apr 15, 1985 | Substantially Equivalent | STRYKER CORP. |
| K841970 | CAMELBACK HANDLE-K841969-LABELING | Jun 19, 1984 | Substantially Equivalent | STAINLESS MFG., INC. |
| K841969 | 6.5MM HEX HANDLE | Jun 19, 1984 | Substantially Equivalent | STAINLESS MFG., INC. |
| K834108 | NEEDLE BENDER TX8225 | Mar 12, 1984 | Substantially Equivalent | TODAY'S MACHINING & DESIGN, INC. |
| K834370 | MULHOLLAN ARTHROSCOPIC NEEDLE CARRIER | Feb 27, 1984 | Substantially Equivalent | ACUFEX MICROSURGICAL, INC. |
| K834369 | CRANE MENISCAL SUTURE SET | Feb 27, 1984 | Substantially Equivalent | ACUFEX MICROSURGICAL, INC. |
| K833943 | MENISCAL SUTURING SYSTEM | Feb 27, 1984 | Substantially Equivalent | DYONICS, INC. |
| K813000 | DISPOSABLE ARTHROSCOPY CANNULA SET | Jan 22, 1982 | Substantially Equivalent | CLINICAL TECHNOLOGY CORP. |
| K803127 | HOWMEDICA KNEE BRUSH | Feb 10, 1981 | Substantially Equivalent | HOWMEDICA CORP. |
| K810267 | FEMORAL CANAL BRUSH | Feb 09, 1981 | Substantially Equivalent | RICHARD'S MEDICAL EQUIP., INC. |
| K802694 | JACOB CHUCK | Nov 12, 1980 | Substantially Equivalent | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| K792670 | SMITH SUBTALAR PEG | Feb 22, 1980 | Substantially Equivalent | DOW CORNING WRIGHT |
FEI Numbers
This FDA classification entry is associated with 1140 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1140 registration numbers. Click on an entry to view related FDA registrations.