Silver Osteotome
FDA 510(k) K772374 · Edward Weck, Inc.
510(k) numberK772374
Submission
- Device name
- Silver Osteotome
- Applicant
- Edward Weck, Inc.
Mchenry, IL, US - Received
- December 27, 1977
- Decision date
- March 9, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDG – Chisel (Osteotome)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KDG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952678 | Sta-Clear Alcohol-Free Endoscopic Anti-Fog KitKDG · Traditional | Avail-Southwest Division | 07/10/1995SE |
| K952200 | Omni-JugKDG · Traditional | Waterstone Medical, Inc. | 06/29/1995SE |
| K894785 | Surgical Chisel/OsteotomeKDG · Traditional | Fdt Precision Machine Co., Inc. | 08/18/1989SE |
| K891471 | Sil-Med Waste Fluid Dump BagKDG · Traditional | Sil-Med Corp. | 08/15/1989SE |
| K872947 | Porex Quality Plastic Surgery InstrumentsKDG · Traditional | Porex Medical | 08/21/1987SE |
| K872092 | Osteotome Set, Hoke, Straight, Set of 5KDG · Traditional | Military Engineering, Inc. | 06/23/1987SE |
| K842824 | Chermel Bone ChiselsKDG · Traditional | Cher Mel Corp. | 08/02/1984SE |
| K772376 | Neivert OsteotomeKDG · Traditional | Edward Weck, Inc. | 03/09/1978SE |
| K772373 | Anderson-Neivert OsteotomeKDG · Traditional | Edward Weck, Inc. | 03/09/1978SE |
| K780135 | Cement Extraction Instrument SetKDG · Traditional | Orthopedic Equipment Co., Inc. | 01/31/1978SE |
More from Orthopedic Equipment Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K915378 | Weck TrocarHET · Traditional | 06/29/1992SE |
| K914690 | LM15(TM), Catalog Number - 523821GCJ · Traditional | 03/23/1992SE |
| K911915 | Hemoclip IIFZP · Traditional | 01/09/1992SE |
| K914470 | Pneumo-Seal(Tm)GCJ · Traditional | 11/29/1991SE |
| K911272 | Endoscopic Needlholder Cat. Number 114705FHG · Traditional | 07/02/1991SE |
| K902108 | Hem-O-Lok(Tm)FZP · Traditional | 08/06/1990SE |
| K902232 | Weck Electrosurgical Generator #174200GEI · Traditional | 08/02/1990SE |
| K897045 | Bowie-Dick Test Card Catalog Number 008018JOJ · Traditional | 02/15/1990SE |
| K871110 | Coronary Artery Bypass Graft (Cabg) MarkerDSY · Traditional | 08/27/1987SE |
| K851251 | Auto/Manual Titanium Hemoclip Ligating Clip 527200FZP · Traditional | 07/02/1985SE |
Questions and answers
When was Silver Osteotome cleared by the FDA?
Silver Osteotome (K772374) received a 510(k) decision of Substantially Equivalent on March 9, 1978, 72 days after the submission was received.
What is the product code of K772374?
The FDA product code is KDG – Chisel (Osteotome), a Class I (low risk) device regulated under 21 CFR 878.4820.