3P Small-Mini Frag System
- Primary DI
- 00841132186282
- Brand
- 3P Small-Mini Frag System
- Company
- ORTHOPEDIATRICS CORP.
- Model
- 00-3135-5510
- Catalog number
- 00-3135-5510
- Device description
- 3PSM 3.5mm T-Plate, 3H Head, 10-Hole
- Published
- 2026-06-10
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Contact Domains#
xxx.comProduct Codes#
| Code | Name |
|---|---|
| HRS | Plate, fixation, bone |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K252600 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00841132186282 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00841132186282 | 00841132186282 | 841132186282 | 0841132186282 |
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, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts#
| Phone | |
|---|---|
| +1(574)268-6379 | xxx@xxx.com |
Regulatory Flags#
- DUNS number
- 796416191
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company#
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|---|---|---|---|---|
| 00840194499248 | Contracture Management | NS-6000-4001 | NS-6000-4001 | 2026-03-02 |
| 00840194499255 | Contracture Management | NS-6000-4101 | NS-6000-4101 | 2026-03-02 |
| 00840194499262 | Contracture Management | NS-6000-4002 | NS-6000-4002 | 2026-03-02 |
| 00840194499279 | Contracture Management | NS-6000-4102 | NS-6000-4102 | 2026-03-02 |
| 00840536823717 | VerteGlide Spinal Growth Guidance System | 03-1721-4503 | 03-1721-4503 | 2026-07-24 |
| 00840536823724 | VerteGlide Spinal Growth Guidance System | 03-1723-5503 | 03-1723-5503 | 2026-07-24 |
| 00841132133200 | PediFlex | 01-1000-001 | 01-1000-001 | 2017-02-15 |
| 00841132133217 | PediFlex | 01-1000-002 | 01-1000-002 | 2017-02-15 |
| 00841132135280 | PediNail | 21-1500-007 | 21-1500-007 | 2017-02-15 |
| 00841132135297 | PediNail | 21-1500-010 | 21-1500-010 | 2017-02-15 |
| 00841132135303 | PediNail | 21-1500-012 | 21-1500-012 | 2017-02-15 |
| 00841132135310 | PediNail | 21-1500-013 | 21-1500-013 | 2017-02-15 |
| 00841132135334 | PediNail | 21-1500-019 | 21-1500-019 | 2017-02-15 |
| 00841132135341 | PediNail | 21-1500-112 | 21-1500-112 | 2017-02-15 |
| 00841132135358 | PediNail | 21-1500-119 | 21-1500-119 | 2017-02-15 |
| 00841132135372 | PediNail | 21-1500-9113 | 21-1500-9113 | 2017-02-15 |
| 00841132135389 | PediNail | 21-1500-9213 | 21-1500-9213 | 2017-02-15 |
| 00841132135396 | PediNail | 21-1500-9214 | 21-1500-9214 | 2017-02-15 |
| 00841132179833 | Vilex Tool | P460-45-100 | P460-45-100 | 2020-03-02 |
| 00841132179888 | Orthex Tool | PP460-15-110 | PP460-15-110 | 2020-03-02 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00688346005356 | Fine Osteotomy System - Femoral plate | Laboratoires Bodycad Inc | HRS | 2026-08-03 |
| 00688346005387 | Fine Osteotomy System - Femoral plate | Laboratoires Bodycad Inc | HRS | 2026-08-03 |
| 00688346005523 | Fine Osteotomy System - Tibial plate | Laboratoires Bodycad Inc | HRS | 2026-08-03 |
| 00688346005554 | Fine Osteotomy System - Tibial plate | Laboratoires Bodycad Inc | HRS | 2026-08-03 |
| 07899258606637 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606644 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606651 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606668 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606675 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606682 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606699 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606705 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606712 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606729 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606736 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606743 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606750 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606767 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606774 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606781 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606798 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606804 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606811 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606828 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606835 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606842 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606859 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606866 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606873 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606880 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |