Camelback HANDLE-K841969-LABELING
FDA 510(k) K841970 · Stainless Mfg., Inc.
510(k) numberK841970
Submission
- Device name
- Camelback HANDLE-K841969-LABELING
- Applicant
- Stainless Mfg., Inc.
Mchenry, IL, US - Received
- May 14, 1984
- Decision date
- June 19, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code LXH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192873 | SX-One MicroKnifeLXH · Traditional | Sonex Health, Inc. | 12/20/2019SE |
| K140414 | Imbibe NeedleLXH · Traditional | Orthovita, Inc. | 04/01/2014SE |
| K101609 | Self Retaining Soft Tissue RetractorLXH · Traditional | Koros USA, Inc. | 12/09/2010SE |
| K001507 | Microperforation InstrumentLXH · Traditional | Smith & Nephew, Inc. | 06/14/2000SE |
| K952495 | Anchors Away Soft Tissue Attachment SystemLXH · Traditional | Orthopedic Systems, Inc. | 01/22/1996SE |
| K943873 | Orthomet Anatomically Guided Carpal Tunnel Release SyLXH · Traditional | Orthomet, Inc. | 04/26/1995SE |
| K944188 | Spinal MarkerLXH · Traditional | Leibinger L.P. | 04/13/1995SE |
| K941896 | Steadman Ligament Graft Passer and ProtectorLXH · Traditional | Depuy, Inc. | 11/07/1994SE |
| K941711 | Hyperflex Flexible GuidewiresLXH · Traditional | Linvatec Corp. | 08/26/1994SE |
| K941605 | Stryker Femoral Canal Brush, Acetabular BrushLXH · Traditional | Stryker Corp. | 08/05/1994SE |
More from Stryker Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K841980 | Side Cutting Serrated BladeHTZ · Traditional | 08/15/1984SE |
| K841982 | Meniscotome 4MM & 5MMHTZ · Traditional | 06/19/1984SE |
| K841981 | 4MM & 5MM FileHTP · Traditional | 06/19/1984SE |
| K841979 | 4MM Cup CurretteHTF · Traditional | 06/19/1984SE |
| K841978 | Lateral Release Knife 5MM & 7MMHTZ · Traditional | 06/19/1984SE |
| K841977 | 5MM Dougle Edge Ring CuretteHTZ · Traditional | 06/19/1984SE |
| K841976 | Hook Knife 4MM & 5MMHTZ · Traditional | 06/19/1984SE |
| K841975 | Rosette Knife 4MMHTZ · Traditional | 06/19/1984SE |
| K841974 | Retrograde Knife 4MM & 5MMHTZ · Traditional | 06/19/1984SE |
| K841973 | Banana Knife SerratedHTZ · Traditional | 06/19/1984SE |
Questions and answers
When was Camelback HANDLE-K841969-LABELING cleared by the FDA?
Camelback HANDLE-K841969-LABELING (K841970) received a 510(k) decision of Substantially Equivalent on June 19, 1984, 36 days after the submission was received.
What is the product code of K841970?
The FDA product code is LXH – Orthopedic Manual Surgical Instrument, a Class I (low risk) device regulated under 21 CFR 888.4540.