Fibula Plate PROlock
- Primary DI
- 09120034302626
- Brand
- Fibula Plate PROlock
- Company
- I.T.S. GmbH
- Model
- 21222-8
- Catalog number
- 21222-8
- Device description
- Fibula Plate PROlock, 8-Hole, Left
- Published
- 2016-09-08
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| HRS | Plate, Fixation, Bone |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K063672 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 09120034302626 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 09120034302626 | 09120034302626 | 9120034302626 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthopaedic fixation plate, non-bioabsorbable | A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 303456917
- Device count
- 1
- DM exempt
- true
- Lot or batch
- true
- Sterilization required before use
- true
Other Devices From This Company#
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|---|---|---|---|---|
| 09120116973843 | Impactor | 1UI105A | 1UI105A | 2024-08-05 |
| 09120116973850 | PF Extension Endcap,+5mm, PPS | 1F0-15-05A-S | 1F0-15-05A-S | 2024-08-05 |
| 09120116973874 | PF Extension Endcap,+10mm, PPS | 1F0-15-10A-S | 1F0-15-10A-S | 2024-08-05 |
| 09120116973881 | PF Extension Endcap,+15mm, PPS | 1F0-15-15A-S | 1F0-15-15A-S | 2024-08-05 |
| 09120116973898 | PF Extension Endcap,+20mm, PPS | 1F0-15-20A-S | 1F0-15-20A-S | 2024-08-05 |
| 09120116973867 | PF Endcap, 0mm PPS | 1F0-10-30A-S | 1F0-10-30A-S | 2024-04-15 |
| 09120034300417 | Bending Iron | 66252-14 | 66252-14 | 2018-11-08 |
| 09120034306419 | Small Plate Bending Iron | KM 47-915 | KM 47-915 | 2018-11-13 |
| 09120034306426 | Small Plate Bending Iron | KM 47-916 | KM 47-916 | 2018-11-13 |
| 09120047301883 | Bending Heaver | KJ.206.14 | KJ.206.14 | 2018-11-14 |
| 09120047301890 | Bending Heaver | KJ.207.14 | KJ.207.14 | 2018-11-14 |
| 09120069815429 | In-Situ Bending Iron | 66261 | 66261 | 2018-11-08 |
| 09120069815436 | In-Situ Bending Iron | 66262 | 66262 | 2018-11-08 |
| 09120069815443 | In-Situ Bending Iron | 66263 | 66263 | 2018-11-08 |
| 09120034302633 | Fibula Plate PROlock | 21222-6 | 21222-6 | 2016-09-08 |
| 09120034302640 | Fibula Plate PROlock | 21222-4 | 21222-4 | 2016-09-08 |
| 09120034302657 | Fibula Plate PROlock | 21221-8 | 21221-8 | 2016-09-08 |
| 09120034302664 | Fibula Plate PROlock | 21221-6 | 21221-6 | 2016-09-08 |
| 09120034302671 | Fibula Plate PROlock | 21221-4 | 21221-4 | 2016-09-08 |
| 09120034302701 | PRS Plate | 21195-8 | 21195-8 | 2016-09-05 |
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