Modification of: Ebi Spinelink System
FDA 510(k) K990999 · Electro-Biology, Inc.
510(k) numberK990999
Submission
- Device name
- Modification of: Ebi Spinelink System
- Applicant
- Electro-Biology, Inc.
Parsippany, NJ, US - Received
- March 25, 1999
- Decision date
- April 14, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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|---|---|---|---|
| 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 |
|---|---|---|
| K992333 | Ebi Omega 21 SystemMNI · Traditional | 10/08/1999SE |
| K992367 | Ebi Xfix Dynafix System Ha Coated ScrewsHWC · Traditional | 09/23/1999SE |
| K991941 | Ebi Xfix DFS Rail SystemKTT · Traditional | 08/19/1999SE |
| K991092 | Ebi Spinelink Anterior Cervical Spinal SystemKWQ · Special | 04/29/1999SE |
| K990303 | Ebi Omega 21 SystemKWP · Traditional | 04/29/1999SE |
| K990459 | Ebi Vuecath Endoscopic SystenHRX · Traditional | 04/23/1999SE |
| K984027 | Ebi Spinelink SystemMNI · Traditional | 01/19/1999SE |
| K982484 | Ebi Vuecath Endoscopic Spinal SystemHRX · Traditional | 10/08/1998SE |
| K982908 | Modification to Ebi Spinelink SystemKWP · Special | 08/28/1998SE |
| K981483 | Ebi DFS Joint Fixator, Model 02800KTT · Traditional | 07/08/1998SE |
Questions and answers
When was Modification of: Ebi Spinelink System cleared by the FDA?
Modification of: Ebi Spinelink System (K990999) received a 510(k) decision of Substantially Equivalent on April 14, 1999, 20 days after the submission was received.
What is the product code of K990999?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.