Rotorblade
FDA 510(k) K983435 · Li Medical Technologies, Inc.
510(k) numberK983435
Submission
- Device name
- Rotorblade
- Applicant
- Li Medical Technologies, Inc.
Shelton, CT, US - Received
- September 29, 1998
- Decision date
- April 29, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAI – Fastener, Fixation, Biodegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262357 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Special | Arthrex, Inc. | 08/07/2026SE |
| K253931 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Traditional | Arthrex, Inc. | 05/28/2026SE |
| K260294 | SF Push-in AnchorMAI · Traditional | Surgical Fusion Technologies GmbH | 03/27/2026SE |
| K254055 | OSSIOfiber® Suture AnchorMAI · Traditional | OSSIO , Ltd. | 02/24/2026SE |
| K251680 | Biosteon® ScrewMAI · Traditional | Biocomposites, Ltd. | 02/17/2026SE |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation KitMAI · Special | Conmed Corporation | 10/15/2025SE |
| K252022 | OSSIOfiber® Interference ScrewMAI · Traditional | OSSIO , Ltd. | 08/19/2025SE |
| K251309 | OSSIOfiber® Suture AnchorMAI · Special | OSSIO , Ltd. | 05/27/2025SE |
| K250544 | Knotilus+ Biocomposite Knotless AnchorMAI · Traditional | Stryker Endoscopy | 05/23/2025SE |
| K250528 | Stryker AlphaVent Knotless SP Biocomposite AnchorMAI · Traditional | Stryker Endoscopy | 05/21/2025SE |
More from Stryker Endoscopy
| 510(k) | Device | Decision |
|---|---|---|
| K002413 | Ultrasorb Suture AnchorMAI · Traditional | 09/19/2000SE |
| K993373 | Rotorblade Suture AnchorMAI · Special | 10/27/1999SE |
| K992938 | Rotorblade Suture AnchorMAI · Special | 09/23/1999SE |
| K981764 | LM AnchorMBI · Abbreviated | 07/13/1998SE |
| K981755 | LM AnchorMBI · Abbreviated | 07/13/1998SE |
| K963288 | LM Bone AnchorMBI · Traditional | 11/13/1996SE |
| K963812 | LM Bone Anchor (Orthopedics)MBI · Traditional | 11/12/1996SE |
| K960825 | LM Anchor or Other Proprietary NameMBI · Traditional | 04/30/1996SE |
| K960439 | LM Bone AnchorMBI · Traditional | 04/18/1996SE |
| K960448 | LM AnchorMBI · Traditional | 04/17/1996SE |
Questions and answers
When was Rotorblade cleared by the FDA?
Rotorblade (K983435) received a 510(k) decision of Substantially Equivalent on April 29, 1999, 212 days after the submission was received.
What is the product code of K983435?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.