| Primary Device ID | 00810060885239 | 
| NIH Device Record Key | e827f6a0-c7ca-4f6e-b6dd-ea87711ec59e | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | MD Orthopaedics | 
| Version Model Number | AFO-2-LW-PFS | 
| Company DUNS | 146220269 | 
| Company Name | MD ORTHOPAEDICS, INC. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | true | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | true | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00810060885239 [Primary] | 
| KNP | Orthosis, Corrective Shoe | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-10-14 | 
| Device Publish Date | 2020-10-06 | 
| 00810060886250 | Ankle foot orthosis, prefabricated (single), to be attached to abduction brace, L1930 each AFO S | 
| 00810060886243 | Ankle foot orthosis, prefabricated (single) with toe stilt, to be attached to abduction brace, L | 
| 00810060885536 | Plantar Flexion Stop with Toe Stilt (single)- articulated ankle joint attached to Ponseti AFO, L | 
| 00810060885529 | Plantar Flexion Stop with Toe Stilt (single)- articulated ankle joint attached to Ponseti AFO, L | 
| 00810060885512 | Plantar Flexion Stop (single) - articulated ankle joint attached to Ponseti AFO, L1971 each AFO- | 
| 00810060885505 | Ankle foot orthosis, prefabricated (single), to be attached to abduction brace, L1930 each AFO S | 
| 00810060885499 | Ankle foot orthosis, prefabricated (single), to be attached to abduction brace, L1930 each AFO S | 
| 00810060885482 | Plantar Flexion Stop (single) - articulated ankle joint attached to Ponseti AFO, L1971 AFO-PFS S | 
| 00810060885475 | Ankle foot orthosis, prefabricated (single), to be attached to abduction brace, L1930 AFO SIZE 3 | 
| 00810060885468 | Plantar Flexion Stop (pair) - articulated ankle joint attached to Ponseti AFO, L1971 x 2 AFO-PFS | 
| 00810060885451 | Ankle foot orthosis, prefabricated (pair), to be attached to abduction brace, L1930 x 2 AFO SIZE | 
| 00810060885444 | Plantar Flexion Stop (single) - articulated ankle joint attached to Ponseti AFO, L1971 AFO-PFS S | 
| 00810060885437 | Ankle foot orthosis, prefabricated (single), to be attached to abduction brace, L1930 AFO SIZE 3 | 
| 00810060885420 | Ankle foot orthosis, prefabricated (single), to be attached to abduction brace, L1930 each AFO S | 
| 00810060885413 | Ankle foot orthosis, prefabricated (single) with toe stilt, to be attached to abduction brace, L | 
| 00810060885406 | Plantar Flexion Stop with Toe Stilt (single)- articulated ankle joint attached to Ponseti AFO, L | 
| 00810060885390 | Plantar Flexion Stop (single) - articulated ankle joint attached to Ponseti AFO, L1971 each AFO- | 
| 00810060885383 | Ankle foot orthosis, prefabricated (single), to be attached to abduction brace, L1930 each AFO S | 
| 00810060885376 | Ankle foot orthosis, prefabricated (single), to be attached to abduction brace, L1930 each AFO S | 
| 00810060885369 | Ankle foot orthosis, prefabricated (pair), to be attached to abduction brace, L1930 x 2 AFO SIZE | 
| 00810060885352 | Ankle foot orthosis, prefabricated (pair) with toe stilt, to be attached to abduction brace, L19 | 
| 00810060885345 | Plantar Flexion Stop with Toe Stilt (pair)- articulated ankle joint attached to Ponseti AFO, L19 | 
| 00810060885338 | Plantar Flexion Stop (pair) - articulated ankle joint attached to Ponseti AFO, L1971 x 2 AFO-PFS | 
| 00810060885321 | Ankle foot orthosis, prefabricated (pair), to be attached to abduction brace, L1930 x 2 AFO SIZE | 
| 00810060885314 | Plantar Flexion Stop (pair) - articulated ankle joint attached to Ponseti AFO, L1971 x 2 AFO-PFS | 
| 00810060885307 | Ankle foot orthosis, prefabricated (pair), to be attached to abduction brace, L1930 x 2 AFO SIZE | 
| 00810060885291 | Plantar Flexion Stop (pair) - articulated ankle joint attached to Ponseti AFO, L1971 x 2 AFO-PFS | 
| 00810060885284 | Ankle foot orthosis, prefabricated (single), to be attached to abduction brace, L1930 each AFO S | 
| 00810060885277 | Ankle foot orthosis, prefabricated (single) with toe stilt, to be attached to abduction brace, L | 
| 00810060885260 | Plantar Flexion Stop with Toe Stilt (single)- articulated ankle joint attached to Ponseti AFO, L | 
| 00810060885253 | Plantar Flexion Stop with Toe Stilt (single)- articulated ankle joint attached to Ponseti AFO, L | 
| 00810060885246 | Plantar Flexion Stop with Toe Stilt (single)- articulated ankle joint attached to Ponseti AFO, L | 
| 00810060885239 | Plantar Flexion Stop (single) - articulated ankle joint attached to Ponseti AFO, L1971 each AFO- | 
| 00810060885222 | Ankle foot orthosis, prefabricated (single), to be attached to abduction brace, L1930 each AFO S | 
| 00810060885215 | Ankle foot orthosis, prefabricated (single), to be attached to abduction brace, L1930 each AFO S | 
| 00810060885208 | Plantar Flexion Stop (single) - articulated ankle joint attached to Ponseti AFO, L1971 AFO-PFS S | 
| 00810060885192 | Ankle foot orthosis, prefabricated (single), to be attached to abduction brace, L1930 AFO SIZE 2 | 
| 00810060885185 | Plantar Flexion Stop (pair) - articulated ankle joint attached to Ponseti AFO, L1971 x 2 AFO-PFS | 
| 00810060885178 | Ankle foot orthosis, prefabricated (pair), to be attached to abduction brace, L1930 x 2 AFO SIZE | 
| 00810060885161 | Plantar Flexion Stop (single) - articulated ankle joint attached to Ponseti AFO, L1971 AFO-PFS S | 
| 00810060885154 | Ankle foot orthosis, prefabricated (single), to be attached to abduction brace, L1930 AFO SIZE 2 | 
| 00810060885147 | Ankle foot orthosis, prefabricated (single), to be attached to abduction brace, L1930 each AFO S | 
| 00810060885130 | Ankle foot orthosis, prefabricated (single), to be attached to abduction brace, L1930 each AFO S | 
| 00810060885123 | Plantar Flexion Stop (single) - articulated ankle joint attached to Ponseti AFO, L1971 each AFO- | 
| 00810060885116 | Plantar Flexion Stop (single) - articulated ankle joint attached to Ponseti AFO, L1971 each AFO- | 
| 00810060885109 | Ankle foot orthosis, prefabricated (pair), to be attached to abduction brace, L1930 x 2 AFO SIZE | 
| 00810060885093 | Plantar Flexion Stop (pair) - articulated ankle joint attached to Ponseti AFO, L1971 x 2 AFO-PFS | 
| 00810060885086 | Ankle foot orthosis, prefabricated (single), to be attached to abduction brace, L1930 each AFO S | 
| 00810060885079 | Plantar Flexion Stop (single) - articulated ankle joint attached to Ponseti AFO, L1971 each AFO- | 
| 00810060885062 | "Plantar Flexion Stop (single) - articulated ankle joint attached to Ponseti AFO, L1971 AFO-PFS | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  MD ORTHOPAEDICS  88637537  not registered Live/Pending | MD Orthopaedics, Inc. 2019-10-01 |