Product code LXH
- Device name
- Orthopedic Manual Surgical Instrument
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4540
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192873 | SX-One MicroKnife | Sonex Health, Inc. | 2019-12-20 |
| K140414 | IMBIBE NEEDLE | Orthovita, Inc. | 2014-04-01 |
| K101609 | SELF RETAINING SOFT TISSUE RETRACTOR | Koros USA, Inc. | 2010-12-09 |
| K001507 | MICROPERFORATION INSTRUMENT | Smith & Nephew, Inc. | 2000-06-14 |
| K952495 | ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM | Orthopedic Systems, Inc. | 1996-01-22 |
| K943873 | ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY | Orthomet, Inc. | 1995-04-26 |
| K944188 | SPINAL MARKER | Leibinger L.P. | 1995-04-13 |
| K941896 | STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR | Depuy, Inc. | 1994-11-07 |
| K941711 | HYPERFLEX FLEXIBLE GUIDEWIRES | Linvatec Corp. | 1994-08-26 |
| K941605 | STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH | Stryker Corp. | 1994-08-05 |
| K933772 | PUNCH SURGICAL | Mahe-Medizintechnik | 1994-02-01 |
| K933242 | SOFAMOR ORTHOPAEDIC INSTRUMENTS | Danek Medical, Inc. | 1994-01-28 |
| K934260 | BARRIER BONE WAX APPLICATOR | Phillips Pharmaceuticals, Inc. | 1994-01-26 |
| K931846 | BIO-PREP | Biomedical Devices, Inc. | 1994-01-21 |
| K930028 | CALMPS: BONE, MASTIN, LEWIN, BRAND | Thomasville Medical Assoc. | 1993-02-16 |
| K921402 | SURGICAL INSTRUMENT, DISPOSABLE | Macro Medical, Inc. | 1992-06-04 |
| K921642 | AMSEN DOUBLE-ENDED FORAMINAL PROBE | Advanced Med/Surg, Inc. | 1992-06-03 |
| K921643 | AMSEN POSTERIOR DISC EVACUATOR | Advanced Med/Surg, Inc. | 1992-06-03 |
| K921644 | AMSEN HOCKEY STICK CHISEL | Advanced Med/Surg, Inc. | 1992-06-03 |
| K921645 | AMSEN SPINE IMPACTOR INSTRUMENTS | Advanced Med/Surg, Inc. | 1992-06-03 |
| K901289 | RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS | Mumtaz I. Malik | 1990-09-28 |
| K901420 | VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8 | Mumtaz I. Malik | 1990-09-28 |
| K901511 | CHISEL, BONE, SURGICAL | Mumtaz I. Malik | 1990-09-28 |
| K901521 | OSTEOTOMES OF VARIOUS TYPES | Mumtaz I. Malik | 1990-09-28 |
| K902819 | LAMINECTOMY ROGEUR | Ruggles Corp. | 1990-08-09 |
| K903247 | ADJUSTABLE ANGLE GUIDE | Onyx Medical Corp. | 1990-07-30 |
| K903257 | DRIVER/EXTRACTOR | Onyx Medical Corp. | 1990-07-30 |
| K903270 | T-HANDLE HEX WRENCH | Onyx Medical Corp. | 1990-07-30 |
| K895172 | KRONNER SACRAL PIN GUIDE | Kronner Medical | 1989-09-12 |
| K891903 | COHN TARGETEER | Orthopedic Systems, Inc. | 1989-05-15 |
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| 00840606189934 | OVERWATCH | SPINAL ELEMENTS, INC. | 2026-10-22 |
| 00840606187640 | OVERWATCH | SPINAL ELEMENTS, INC. | 2026-10-22 |
| 00840606187121 | Primus | SPINAL ELEMENTS, INC. | 2026-10-22 |
| 00840606187091 | ALIF Disc Prep | SPINAL ELEMENTS, INC. | 2026-10-22 |
| 00840606186810 | SAPPHIRE X | SPINAL ELEMENTS, INC. | 2026-10-22 |
| 00840606186735 | SAPPHIRE X | SPINAL ELEMENTS, INC. | 2026-10-22 |
| 00840606186704 | SAPPHIRE X | SPINAL ELEMENTS, INC. | 2026-10-22 |
| 00840606186674 | SAPPHIRE X | SPINAL ELEMENTS, INC. | 2026-10-22 |
| 00840606186643 | SAPPHIRE X | SPINAL ELEMENTS, INC. | 2026-10-22 |
| 00840606186612 | SAPPHIRE X | SPINAL ELEMENTS, INC. | 2026-10-22 |
| 00840606186575 | SAPPHIRE X | SPINAL ELEMENTS, INC. | 2026-10-22 |
| 00840606186506 | Lateral | SPINAL ELEMENTS, INC. | 2026-10-22 |
| 00810141040892 | Foundation Surgical Instruments | FOUNDATION SURGICAL GROUP INC | 2026-10-22 |
| 00810141040915 | Foundation Surgical Instruments | FOUNDATION SURGICAL GROUP INC | 2026-10-22 |
| 00810141040953 | Foundation Surgical Instruments | FOUNDATION SURGICAL GROUP INC | 2026-10-22 |
| 00810141040977 | Foundation Surgical Instruments | FOUNDATION SURGICAL GROUP INC | 2026-10-22 |
| 00810141047532 | Foundation Surgical Instruments | FOUNDATION SURGICAL GROUP INC | 2026-10-22 |
| 00810141047549 | Foundation Surgical Instruments | FOUNDATION SURGICAL GROUP INC | 2026-10-22 |
| 00840314270351 | gSource | GSOURCE LLC | 2026-10-22 |
| 00840606175234 | Primus | SPINAL ELEMENTS, INC. | 2026-10-22 |
| 00840606185820 | Primus | SPINAL ELEMENTS, INC. | 2026-10-22 |
| 00840606186513 | Lateral | SPINAL ELEMENTS, INC. | 2026-10-22 |
| 00812926021461 | Arsenal Ankle | Trilliant Surgical, LLC | 2017-03-15 |
| 07613154731800 | NA | Stryker Leibinger GmbH & Co. KG | 2017-01-11 |
| 07613154732685 | NA | Stryker Leibinger GmbH & Co. KG | 2017-01-11 |
| 04546540356628 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-08 |
| 07613154185443 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-08 |
| 04546540256805 | NA | Stryker Leibinger GmbH & Co. KG | 2016-10-19 |