Panalok Absorbable Suture Anchor System
FDA 510(k) K950272 · ETHICON, Inc.
510(k) numberK950272
Submission
- Device name
- Panalok Absorbable Suture Anchor System
- Applicant
- ETHICON, Inc.
Somerville, NJ, US - Received
- January 23, 1995
- Decision date
- January 18, 1996
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- JDR – Staple, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K243658 | TMC Compression Implant SystemJDR · Special | Treace Medical Concepts | 12/26/2024SE |
| K242415 | TMC Compression Implant SystemJDR · Special | Treace Medical Concepts | 09/06/2024SE |
| K240212 | COGNiTiON Staple SystemJDR · Special | Ortho Solutions UK , Ltd. | 02/23/2024SE |
| K232990 | ATOMIC Nitinol Fixation SystemJDR · Traditional | Rmr Ortho, LLC | 01/12/2024SE |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesJDR · Traditional | Novastep | 12/04/2023SE |
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Questions and answers
When was Panalok Absorbable Suture Anchor System cleared by the FDA?
Panalok Absorbable Suture Anchor System (K950272) received a 510(k) decision of Substantially Equivalent for Some Indications on January 18, 1996, 360 days after the submission was received.
What is the product code of K950272?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.