Kambin Spinal Instrument Set
FDA 510(k) K853678 · Pilling Co.
510(k) numberK853678
Submission
- Device name
- Kambin Spinal Instrument Set
- Applicant
- Pilling Co.
Fort Washington, PA, US - Received
- September 3, 1985
- Decision date
- September 24, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HTZ – Instrument, Cutting, Orthopedic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K850527 | Arthroscopy Suction Biopsy PunchHTZ · Traditional | T. Korossurgical Instruments Corp. | 03/14/1985SE |
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| K842774 | Codman Suction Punch-Product CodesHTZ · Traditional | Codman & Shurtleff, Inc. | 07/27/1984SE |
| K842111 | Kogan Endospeculum 9-1/2HTZ · Traditional | J. Sklar Mfg. Co., Inc. | 06/19/1984SE |
| K841982 | Meniscotome 4MM & 5MMHTZ · Traditional | Stainless Mfg., Inc. | 06/19/1984SE |
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More from Stainless Mfg., Inc.
| 510(k) | Device | Decision |
|---|---|---|
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| K934427 | Pilling Laparoscopic InstrumentationGEI · Traditional | 01/10/1994SE |
| K925370 | Triangular Jaw Microlaryngeal ForcepsELW · Traditional | 03/18/1993SE |
| K925198 | Kaiser No Cannula Thoracoscopy/Laparoscopy InstrGCJ · Traditional | 02/12/1993SE |
| K922971 | No-Scalpel Vascetomy InstrumentsKOA · Traditional | 09/23/1992SE |
| K914015 | Clement-Pilling Cholangiography Cath Guide/ClampGBZ · Traditional | 11/21/1991SE |
| K911099 | Mehigan-Pilling Angioscopic Vascular Instrum. LineDWX · Traditional | 06/25/1991SE |
| K911100 | Mehigan-Pilling Phlebetome TMMGZ · Traditional | 06/21/1991SE |
| K904507 | Pilling Brush ValvulotomeDWQ · Traditional | 03/01/1991SE |
| K884946 | Jehle Coronary Perfusion CathetersKRA · Traditional | 02/06/1989SE |
Questions and answers
When was Kambin Spinal Instrument Set cleared by the FDA?
Kambin Spinal Instrument Set (K853678) received a 510(k) decision of Substantially Equivalent on September 24, 1985, 21 days after the submission was received.
What is the product code of K853678?
The FDA product code is HTZ – Instrument, Cutting, Orthopedic, a Class I (low risk) device regulated under 21 CFR 878.4800.