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Quantum™* Flex 13-55-Pr-45

by Pioneer Surgical Technology Inc.

Quantum™* Flex 13-55-Pr-45 is a Class II device made by Pioneer Surgical Technology Inc., cleared under FDA 510(k) K101790 on 7 Mar 2011 and listed in FDA GUDID since 6 Nov 2015 (UDI-DI 00846468022419), active (FDA 510(k)), not in commercial distribution (GUDID) as of 8 Nov 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

510(k) K101790

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00846468022419 UDI-DI Date6 Nov 2015ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK101790 Date7 Mar 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K101790 decided 7 Mar 2011 Active
  • FDA GUDID UDI-DI 00846468022419 listed 6 Nov 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K101790
  2. Listed FDA GUDID 00846468022419

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Quantum™* Flex
Generic name
Bone-screw internal spinal fixation system, non-sterile
Model / reference
13-55-PR-45
Primary DI / UDI-DI
00846468022419
510(k) Number
FDA product code
MNI, KWQ, MNH, KWP, NKB
GMDN term
Bone-screw internal spinal fixation system, non-sterile
Device class
Class II
Regulation number
888.3070, 888.3060, 888.3050
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code MNI (ORTHOSIS, SPINAL PEDICLE FIXATION).

Other devices from Pioneer Surgical Technology Inc.

See all devices from Pioneer Surgical Technology Inc. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)