Exact Osteotomy System
- Primary DI
- B562OGSPDG20
- Brand
- Exact Osteotomy System
- Company
- Wishbone Medical, Inc.
- Model
- OGS-PDG2
- Device description
- EXACT OSTEOTOMY SYSTEM - PASA/DMAA (2-STAGE GUIDE)
- Published
- 2021-09-16
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| FZX | Guide, Surgical, Instrument |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| B562OGSPDG20 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Osteotomy guide, single-use | A surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 062355158
- Device count
- 1
- Premarket exempt
- true
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| B562PKBVF050 | WISHBONE MG | PK-BVF05 | 2020-07-01 | |
| B562PKBVF100 | WISHBONE MG | PK-BVF10 | 2020-07-01 | |
| B562PKBVF150 | WISHBONE MG | PK-BVF15 | 2020-07-01 | |
| B562PKGS000100 | Micro Surgery Kit | PK-GS0001 | PK-GS0001 | 2024-12-30 |
| B562PKGS000200 | Minor Surgery Kit | PK-GS0002 | PK-GS0002 | 2024-12-30 |
| B562PK301ELB1600 | K-Wire | PK-301-ELB160 | 2023-03-16 | |
| B562PK301ELB2000 | K-Wire | PK-301-ELB200 | 2023-03-16 | |
| B562PK301EXT1250 | K-Wire | PK-301-ELB200 | 2023-03-16 | |
| B562PKEFC0416S080 | WishFIX | PK-EFC0416S-08 | 2023-03-16 | |
| B562PKOCD02010 | AlloMate | PK-OCD020-1 | 2023-03-16 | |
| B562PKOCD02510 | AlloMate | PK-OCD025-1 | 2023-03-16 | |
| B562PKOCD03010 | AlloMate | PK-OCD030-1 | 2023-03-16 | |
| B562PKOCD03510 | AlloMate | PK-OCD035-1 | 2023-03-16 | |
| B562PKOCD04010 | AlloMate | PK-OCD040-1 | 2023-03-16 | |
| B562066582BWB0 | Sterile Spine Pedicle Screw System | 06.6582B-WB | 06.6582B-WB | 2022-07-19 |
| B562066587BWB0 | Sterile Spine Pedicle Screw System | 06.6587B-WB | 06.6587B-WB | 2022-07-19 |
| B56213904001220S00 | WishBone K-Wire System | 13-904-001220S-0 | 13-904-001220S-0 | 2022-07-18 |
| B56213904001220S10 | WishBone K-Wire System | 13-904-001220S-1 | 13-904-001220S-1 | 2022-07-18 |
| B56213904001620S00 | WishBone K-Wire System | 13-904-001620S-0 | 13-904-001620S-0 | 2022-07-18 |
| B56213904001620S10 | WishBone K-Wire System | 13-904-001620S-1 | 13-904-001620S-1 | 2022-07-18 |
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| 06932503563857 | Additional Working Channel | Micro-Tech (Nanjing) Co., Ltd. | FZX | 2026-09-30 |
| 06932503563864 | Additional Working Channel | Micro-Tech (Nanjing) Co., Ltd. | FZX | 2026-09-30 |
| 06932503563871 | Additional Working Channel | Micro-Tech (Nanjing) Co., Ltd. | FZX | 2026-09-30 |
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