Orthopediatrics® Instrumentation
by OrthoPediatrics Corp. 13 variants
Ref 01-1300-0032Model 01-1007-0100
Orthopediatrics® Instrumentation (01-1300-0032) is a device classified as Class I and Class II in the US made by Orthopediatrics Corp., registered in EUDAMED on 8 Aug 2025 (Basic UDI-DI 084113210999CASECS), cleared under FDA 510(k) K203573 on 4 Feb 2021 (1 earlier submission) and listed in FDA GUDID since 15 Apr 2024 (UDI-DI 00841132178508), active as of 24 Oct 2026.
Active
CE MDR 510(k)
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number084113210999CASECS 00841132178508 | Date8 Aug 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00841132178508 | Date15 Apr 2024 | StatusListed |
| United States | FDA 510(k)SESE GUDID | NumberK203573 | Date4 Feb 2021 | StatusActive |
Official records
- EUDAMED public site 084113210999CASECS
- AccessGUDID record 00840194465267
- AccessGUDID record 00840194465304
- AccessGUDID record 00840194465137
- AccessGUDID record 00840194466080
- AccessGUDID record 00841132145074
- FDA 510(k) database K203573
- FDA 510(k) database K190992
Across registries
- EUDAMED Basic UDI-DI 084113210999CASECS registered 8 Aug 2025 Active
- FDA 510(k) K203573 decided 4 Feb 2021 Active
- FDA GUDID UDI-DI 00841132178508 listed 15 Apr 2024 Listed
Timeline
- Cleared FDA 510(k) K190992
- Cleared FDA 510(k) K203573
- Listed FDA GUDID 00841132178508
- Registered EUDAMED 084113210999CASECS
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Orthopediatrics® Instrumentation EUDAMEDOrthoPediatrics Hardware Removal GUDIDStainless Steel Guide Wires GUDIDOrthoPediatrics PediFoot Deformity Correction System GUDIDPediatric Nailing Platform Femur GUDIDResponse Navigation GUDIDPediatric Nailing Platform | Tibia GUDIDOrthopediatrics Instrumentation GUDIDPediFoot Deformity Correction System GUDIDBroken Screw Removal Instruments GUDID
- Generic name
- Surgical screwdriver, reusableSurgical implant handling forcepsOrthopaedic guidewire, single-useInstrument tray, reusableOsteotomy guide, reusableOrthopaedic inorganic implant inserter/extractor, reusableTendon/ligament tunnellerBone tap, reusableOrthopaedic inorganic implant inserter/extractor, single-use
- Model / Ref / Catalog
- 01-1007-0100 EUDAMED01-1300-0032 EUDAMED01-9200-0045 GUDID01-9200-1000 GUDID01-9200-0010 GUDID01-9473-9180 GUDID01-1007-0004 GUDID01-1007-0037 GUDID01-9473-4023 GUDID01-1501-0086 GUDID03-1800-0001 GUDID01-1007-1727 GUDID01-1510-0065 GUDID01-9473-4115 GUDID01-1007-1232 GUDID01-1007-0018 GUDID01-1007-0041 GUDID01-1007-1842 GUDID01-1007-0013 GUDID01-1501-0101 GUDID01-1007-1725 GUDID01-1007-1849 GUDID01-9473-9220 GUDID01-9473-0030 GUDID01-1800-6035 GUDID01-9473-5107 GUDID01-9473-6115 GUDID01-9473-6310 GUDID01-9473-0108 GUDID01-9473-8030 GUDID01-1007-0136 GUDID01-1007-1721 GUDID01-1007-0732 GUDID01-9473-6325 GUDID01-1501-0064 GUDID01-1007-1710 GUDID01-1800-3060 GUDID01-9473-6107 GUDID01-1800-6037 GUDID01-9473-0035 GUDID01-1007-1737 GUDID01-9200-0150 GUDID01-1007-1848 GUDID01-1800-6036 GUDID01-9473-8120 GUDID01-9200-1025 GUDID01-9200-1035 GUDID01-1800-1060 GUDID01-1800-1055 GUDID01-9473-5115 GUDID01-9473-0015 GUDID01-1007-0137 GUDID
- Primary DI / UDI-DI
- 00841132178508 EUDAMED00840194465267 GUDID00840194465304 GUDID00840194465137 GUDID00840194466080 GUDID00841132145074 GUDID00841132159415 GUDID00840194465465 GUDID00840194405669 GUDID00841132184639 GUDID00841132159576 GUDID00840194462730 GUDID00840194465410 GUDID00841132174357 GUDID00841132159194 GUDID00841132178812 GUDID00841132159705 GUDID00841132159149 GUDID00840194407670 GUDID00841132159552 GUDID00841132159774 GUDID00840194465908 GUDID00840194465878 GUDID00841132181140 GUDID00840194465472 GUDID00840194465618 GUDID00840194465946 GUDID00840194465786 GUDID00840194465748 GUDID00841132159422 GUDID00841132159538 GUDID00841132159866 GUDID00840194465977 GUDID00840194405423 GUDID00841132159491 GUDID00841132181119 GUDID00840194465571 GUDID00841132181164 GUDID00840194465885 GUDID00841132159675 GUDID00840194465298 GUDID00841132159767 GUDID00841132181157 GUDID00840194465724 GUDID00840194478434 GUDID00840194478458 GUDID00841132173121 GUDID00841132144718 GUDID00840194465519 GUDID00840194465854 GUDID00841132159439 GUDID
- Basic UDI-DI
- 084113210999CASECS
- FDA product code
- KIJ, HXX, HTD, LHX, HRS, FZX, FSM, HSB, LXH, HWQ, OLO, GFC
- EMDN code
- L99 Surgical instruments, reusable - other
- GMDN term
- Surgical screwdriver, reusableSurgical implant handling forcepsOrthopaedic guidewire, single-useInstrument tray, reusableOsteotomy guide, reusableOrthopaedic inorganic implant inserter/extractor, reusableTendon/ligament tunnellerBone tap, reusableOrthopaedic inorganic implant inserter/extractor, single-use
- Device class
- Class I EUDAMEDGUDIDClass II GUDID
- Regulation number
- 878.4820, 888.4540, 878.4800, 870.5800, 888.3030, 888.3020, 882.4560
- EU registration type
- Standard device
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / reference | 01-1007-0100 01-1300-0032 | 01-9200-0045 01-9200-1000 01-9200-0010 01-9473-9180 01-1007-0004 01-1007-0037 01-9473-4023 01-1501-0086 03-1800-0001 01-1007-1727 01-1510-0065 01-9473-4115 01-1007-1232 01-1007-0018 01-1007-0041 01-1007-1842 01-1007-0013 01-1501-0101 01-1007-1725 01-1007-1849 01-9473-9220 01-9473-0030 01-1800-6035 01-9473-5107 01-9473-6115 01-9473-6310 01-9473-0108 01-9473-8030 01-1007-0136 01-1007-1721 01-1007-0732 01-9473-6325 01-1501-0064 01-1007-1710 01-1800-3060 01-9473-6107 01-1800-6037 01-9473-0035 01-1007-1737 01-9200-0150 01-1007-1848 01-1800-6036 01-9473-8120 01-9200-1025 01-9200-1035 01-1800-1060 01-1800-1055 01-9473-5115 01-9473-0015 01-1007-0137 |
| Primary DI / UDI-DI | 00841132178508 | 00840194465267 00840194465304 00840194465137 00840194466080 00841132145074 00841132159415 00840194465465 00840194405669 00841132184639 00841132159576 00840194462730 00840194465410 00841132174357 00841132159194 00841132178812 00841132159705 00841132159149 00840194407670 00841132159552 00841132159774 00840194465908 00840194465878 00841132181140 00840194465472 00840194465618 00840194465946 00840194465786 00840194465748 00841132159422 00841132159538 00841132159866 00840194465977 00840194405423 00841132159491 00841132181119 00840194465571 00841132181164 00840194465885 00841132159675 00840194465298 00841132159767 00841132181157 00840194465724 00840194478434 00840194478458 00841132173121 00841132144718 00840194465519 00840194465854 00841132159439 |
| Device class | Class I | Class I Class II |
| Sterilise before use | Yes | Yes No |
Manufacturer details
- EUDAMED SRN
- US-MF-000001776
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
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